Trial Outcomes & Findings for A Safety and Efficacy Study of CC-90011 in Participants With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas (NCT NCT02875223)
NCT ID: NCT02875223
Last Updated: 2025-04-20
Results Overview
Dose-limiting toxicities (DLTs) during dose escalation are defined as follows, occurring within the Cycle 1 (28 days) DLT assessment period, unless clearly unrelated to CC-90011: Any Grade 4 non-hematologic toxicity; any non-hematologic toxicity Grade ≥ 3 except Grade 3 diarrhea, nausea, or vomiting of ≤ 3 days duration, Grade 3 rash resolving to Grade ≤ 2 within 7 days without recurrence, and Grade 3 fatigue resolving to Grade ≤ 2 within 7 days without recurrence. Hematological toxicities include febrile neutropenia, Grade 4 neutropenia \> 7 days, Grade 4 thrombocytopenia \> 7 days, or Grade ≥ 3 thrombocytopenia with significant bleeding. Any AE necessitating dose reduction during Cycle 1, or any other toxicity deemed dose-limiting by the safety committee. The MTD is the highest dose at which less than 33% of the population treated with CC-90011 suffer a DLT in the first cycle and at least 6 evaluable participants have been treated at this dose.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
75 participants
Primary outcome timeframe
Cycle 1 (Each cycle is of 28 days)
Results posted on
2025-04-20
Participant Flow
Participants were not enrolled in Part C and Part D as the study was terminated early.
Participant milestones
| Measure |
Part A 1.25 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received CC-90011 capsule orally once per week of different doses.
|
Part A 2.5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
|
Part A 5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
|
Part A 10 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
|
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
|
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
|
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
|
Part A 80 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
|
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
|
Part B - Lung NETs - 60 mg
Participants with advanced low/intermediate-grade Lung Neuroendocrine tumors (NETs) received 60 mg of CC-90011 capsule orally once per week.
|
Part B - NEPC - 60 mg
Participants with neuroendocrine prostate carcinoma (NEPC) received 60 mg of CC-90011 capsule orally once per week.
|
Part B - MZL - 60 mg
Participants with relapsed and/or refractory (R/R) non-Hodgkin lymphoma (NHL) (marginal zone lymphoma \[MZL\], including extranodal marginal zone lymphoma \[EMZL\], splenic marginal zone lymphoma \[SMZL\], nodal marginal zone lymphoma \[NMZL\], and histologic transformation of marginal zone lymphoma (MZL) received 60 mg of CC-90011 capsule orally once per week.
|
Part B - Japanese Cohort - 60 mg
Japanese participants with relapsed and/or refractory (R/R) advanced unresectable solid tumors (including grade 2 neuroendocrine neoplasm \[NENs\]/NETs) and R/R non-Hodgkin lymphoma (NHLs) (including diffuse large B-cell lymphoma \[DLBCL\] and follicular lymphoma \[FL\] or MZL) received 60 mg of CC-90011 capsule orally once per week
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
6
|
4
|
5
|
6
|
6
|
10
|
4
|
14
|
2
|
3
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
6
|
4
|
5
|
6
|
6
|
10
|
4
|
14
|
2
|
3
|
6
|
Reasons for withdrawal
| Measure |
Part A 1.25 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received CC-90011 capsule orally once per week of different doses.
|
Part A 2.5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
|
Part A 5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
|
Part A 10 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
|
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
|
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
|
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
|
Part A 80 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
|
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
|
Part B - Lung NETs - 60 mg
Participants with advanced low/intermediate-grade Lung Neuroendocrine tumors (NETs) received 60 mg of CC-90011 capsule orally once per week.
|
Part B - NEPC - 60 mg
Participants with neuroendocrine prostate carcinoma (NEPC) received 60 mg of CC-90011 capsule orally once per week.
|
Part B - MZL - 60 mg
Participants with relapsed and/or refractory (R/R) non-Hodgkin lymphoma (NHL) (marginal zone lymphoma \[MZL\], including extranodal marginal zone lymphoma \[EMZL\], splenic marginal zone lymphoma \[SMZL\], nodal marginal zone lymphoma \[NMZL\], and histologic transformation of marginal zone lymphoma (MZL) received 60 mg of CC-90011 capsule orally once per week.
|
Part B - Japanese Cohort - 60 mg
Japanese participants with relapsed and/or refractory (R/R) advanced unresectable solid tumors (including grade 2 neuroendocrine neoplasm \[NENs\]/NETs) and R/R non-Hodgkin lymphoma (NHLs) (including diffuse large B-cell lymphoma \[DLBCL\] and follicular lymphoma \[FL\] or MZL) received 60 mg of CC-90011 capsule orally once per week
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Other reasons
|
0
|
0
|
1
|
0
|
1
|
2
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Progressive disease
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
12
|
2
|
3
|
6
|
|
Overall Study
Death
|
4
|
4
|
3
|
4
|
2
|
3
|
5
|
7
|
3
|
2
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Safety and Efficacy Study of CC-90011 in Participants With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas
Baseline characteristics by cohort
| Measure |
Part A 1.25 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received CC-90011 capsule orally once per week of different doses.
|
Part A 2.5 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
|
Part A 5 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
|
Part A 10 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
|
Part A 20 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
|
Part A 40 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
|
Part A 60 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
|
Part A 80 mg
n=10 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
|
Part A 120 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
|
Part B - Lung NETs - 60 mg
n=14 Participants
Participants with advanced low/intermediate-grade Lung Neuroendocrine tumors (NETs) received 60 mg of CC-90011 capsule orally once per week.
|
Part B - NEPC - 60 mg
n=2 Participants
Participants with neuroendocrine prostate carcinoma (NEPC) received 60 mg of CC-90011 capsule orally once per week.
|
Part B - MZL - 60 mg
n=3 Participants
Participants with relapsed and/or refractory (R/R) non-Hodgkin lymphoma (NHL) (marginal zone lymphoma \[MZL\], including extranodal marginal zone lymphoma \[EMZL\], splenic marginal zone lymphoma \[SMZL\], nodal marginal zone lymphoma \[NMZL\], and histologic transformation of marginal zone lymphoma (MZL) received 60 mg of CC-90011 capsule orally once per week.
|
Part B - Japanese Cohort - 60 mg
n=6 Participants
Japanese participants with relapsed and/or refractory (R/R) advanced unresectable solid tumors (including grade 2 neuroendocrine neoplasm \[NENs\]/NETs) and R/R non-Hodgkin lymphoma (NHLs) (including diffuse large B-cell lymphoma \[DLBCL\] and follicular lymphoma \[FL\] or MZL) received 60 mg of CC-90011 capsule orally once per week
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
8 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
7 Participants
n=62 Participants
|
2 Participants
n=95 Participants
|
1 Participants
n=129 Participants
|
4 Participants
n=36 Participants
|
45 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
7 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
2 Participants
n=129 Participants
|
2 Participants
n=36 Participants
|
30 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
1 Participants
n=129 Participants
|
2 Participants
n=36 Participants
|
34 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
7 Participants
n=62 Participants
|
2 Participants
n=95 Participants
|
2 Participants
n=129 Participants
|
4 Participants
n=36 Participants
|
41 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
7 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
6 Participants
n=36 Participants
|
56 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
7 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
3 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
19 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
6 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
7 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
50 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
7 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
3 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
19 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (Each cycle is of 28 days)Population: DLT Evaluable Population includes participants in Part A are evaluable for DLT if they received at least 75% of the total planned dose of CC-90011 during Cycle 1.
Dose-limiting toxicities (DLTs) during dose escalation are defined as follows, occurring within the Cycle 1 (28 days) DLT assessment period, unless clearly unrelated to CC-90011: Any Grade 4 non-hematologic toxicity; any non-hematologic toxicity Grade ≥ 3 except Grade 3 diarrhea, nausea, or vomiting of ≤ 3 days duration, Grade 3 rash resolving to Grade ≤ 2 within 7 days without recurrence, and Grade 3 fatigue resolving to Grade ≤ 2 within 7 days without recurrence. Hematological toxicities include febrile neutropenia, Grade 4 neutropenia \> 7 days, Grade 4 thrombocytopenia \> 7 days, or Grade ≥ 3 thrombocytopenia with significant bleeding. Any AE necessitating dose reduction during Cycle 1, or any other toxicity deemed dose-limiting by the safety committee. The MTD is the highest dose at which less than 33% of the population treated with CC-90011 suffer a DLT in the first cycle and at least 6 evaluable participants have been treated at this dose.
Outcome measures
| Measure |
Part A 1.25 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
|
Part A 2.5 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
|
Part A 5 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
|
Part A 10 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
|
Part A 20 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
|
Part A 40 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
|
Part A 60 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
|
Part A 80 mg
n=9 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
|
Part A 120 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A - Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (Each cycle is of 28 days)Population: DLT Evaluable Population includes participants in Part A are evaluable for DLT if they received at least 75% of the total planned dose of CC-90011 during Cycle 1.
The MTD is the highest dose at which less than 33% of the population treated with CC-90011 suffer a DLT in the first cycle and at least 6 evaluable participants have been treated at this dose. Dose-limiting toxicities (DLTs) during dose escalation are defined as follows, occurring within the Cycle 1 (28 days) DLT assessment period, unless clearly unrelated to CC-90011: Any Grade 4 non-hematologic toxicity; any non-hematologic toxicity Grade ≥ 3 except Grade 3 diarrhea, nausea, or vomiting of ≤ 3 days duration, Grade 3 rash resolving to Grade ≤ 2 within 7 days without recurrence, and Grade 3 fatigue resolving to Grade ≤ 2 within 7 days without recurrence. Hematological toxicities include febrile neutropenia, Grade 4 neutropenia \> 7 days, Grade 4 thrombocytopenia \> 7 days, or Grade ≥ 3 thrombocytopenia with significant bleeding. Any AE necessitating dose reduction during Cycle 1, or any other toxicity deemed dose-limiting by the safety committee.
Outcome measures
| Measure |
Part A 1.25 mg
n=47 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
|
Part A 2.5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
|
Part A 5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
|
Part A 10 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
|
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
|
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
|
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
|
Part A 80 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
|
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A - Maximum Tolerated Dose (MTDs)
|
60 milligram
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose (Day 1) till disease progression or death due to any cause (up to 803 days)Population: The Treated Population included all participants who enrolled and received at least 1 dose of CC-90011 and prespecified to be reported for Part A only.
The Clinical benefit rate (CBR) is defined as percentage of participants with tumor responses (as assessed by the Investigators) of CR, PR and durable SD (SD of ≥ 4 months duration). Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \\\>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Stable Disease (SD) is concluded when the response does not qualify for CR, PR or Progression. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
Outcome measures
| Measure |
Part A 1.25 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
|
Part A 2.5 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
|
Part A 5 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
|
Part A 10 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
|
Part A 20 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
|
Part A 40 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
|
Part A 60 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
|
Part A 80 mg
n=10 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
|
Part A 120 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A - Clinical Benefit Rate (CBR) as Per Confirmed Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST 1.1)
|
0.0 percentage of participants
Interval 0.0 to 60.2
|
0.0 percentage of participants
Interval 0.0 to 52.2
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
0.0 percentage of participants
Interval 0.0 to 60.2
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
30.0 percentage of participants
Interval 6.7 to 65.2
|
0.0 percentage of participants
Interval 0.0 to 60.2
|
SECONDARY outcome
Timeframe: From first dose (Day 1) untill disease progression or death due to any cause (up to 803 days)Population: The Treated Population included all participants who enrolled and received at least 1 dose of CC-90011 and prespecified to be reported for Part A only
The Objective Response Rate (ORR) is defined as the percentage of participants whose best response is CR or PR. Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \\\>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
Outcome measures
| Measure |
Part A 1.25 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
|
Part A 2.5 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
|
Part A 5 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
|
Part A 10 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
|
Part A 20 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
|
Part A 40 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
|
Part A 60 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
|
Part A 80 mg
n=10 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
|
Part A 120 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A - Objective Response Rate as Per Confirmed Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST 1.1)
|
0.0 percentage of participants
Interval 0.0 to 60.2
|
0.0 percentage of participants
Interval 0.0 to 52.2
|
0.0 percentage of participants
Interval 0.0 to 45.9
|
0.0 percentage of participants
Interval 0.0 to 60.2
|
0.0 percentage of participants
Interval 0.0 to 52.2
|
0.0 percentage of participants
Interval 0.0 to 45.9
|
0.0 percentage of participants
Interval 0.0 to 45.9
|
10.0 percentage of participants
Interval 0.3 to 44.5
|
0.0 percentage of participants
Interval 0.0 to 60.2
|
SECONDARY outcome
Timeframe: From first dose (Day 1) until disease progression or death due to any cause (up to 803 days)Population: The Treated Population included all participants who enrolled and received at least 1 dose of CC-90011. Treated Population with Confirmed Best Response of CR or PR. Prespecified to be reported for Part A only.
Duration of response is measured from the time when criteria for CR/PR are first met (whichever is first recorded) until the first date at which progressive disease is objectively documented. Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \\\>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
Outcome measures
| Measure |
Part A 1.25 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
|
Part A 2.5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
|
Part A 5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
|
Part A 10 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
|
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
|
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
|
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
|
Part A 80 mg
n=1 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
|
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A - Duration of Response (DoR) Based on Confirmed Responses
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA months
Not estimated due to inadequate number of events with CR or PR.
|
—
|
SECONDARY outcome
Timeframe: From first dose (Day 1) until disease progression or death due to any cause (up to 803 days)Population: The Treated Population included all participants who enrolled and received at least 1 dose of CC-90011. Prespecified to be reported for Part A only.
Progression-Free Survival (PFS) is defined as the time from the first dose of CC-90011 to the first occurrence of disease progression or death from any cause based on Kaplan-Meier methodology. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
Outcome measures
| Measure |
Part A 1.25 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
|
Part A 2.5 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
|
Part A 5 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
|
Part A 10 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
|
Part A 20 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
|
Part A 40 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
|
Part A 60 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
|
Part A 80 mg
n=10 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
|
Part A 120 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A - Progression-Free Survival (PFS)
|
96.0 days
Interval 50.0 to 103.0
|
53.0 days
Interval 50.0 to 189.0
|
107.0 days
Interval 22.0 to
Not estimated due to inadequate number of events
|
51.5 days
Interval 22.0 to 106.0
|
588.0 days
Interval 50.0 to 588.0
|
162.0 days
Interval 20.0 to
Not estimated due to inadequate number of events
|
111.5 days
Interval 53.0 to
Not estimated due to inadequate number of events
|
52.0 days
Interval 17.0 to 164.0
|
107.0 days
Interval 61.0 to 238.0
|
SECONDARY outcome
Timeframe: From first dose (Day 1) until death due to any cause (up to 803 days)Population: The Treated Population included all participants who enrolled and received at least 1 dose of CC-90011. Prespecified to be reported for Part A only.
Overall Survival (OS) is defined as the time from the first dose of study drug to death due to any cause based on Kaplan-Meier methodology.
Outcome measures
| Measure |
Part A 1.25 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
|
Part A 2.5 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
|
Part A 5 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
|
Part A 10 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
|
Part A 20 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
|
Part A 40 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
|
Part A 60 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
|
Part A 80 mg
n=10 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
|
Part A 120 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A - Overall Survival (OS)
|
315.0 days
Interval 108.0 to 803.0
|
189.0 days
Interval 53.0 to 204.0
|
611.0 days
Interval 78.0 to
Not estimated due to inadequate number of events
|
322.5 days
Interval 114.0 to 593.0
|
NA days
Interval 116.0 to
Not estimated due to inadequate number of events
|
NA days
Interval 81.0 to
Not estimated due to inadequate number of events
|
NA days
Interval 153.0 to
Not estimated due to inadequate number of events
|
139.0 days
Interval 27.0 to
Not estimated due to inadequate number of events
|
238.0 days
Interval 185.0 to
Not estimated due to inadequate number of events
|
SECONDARY outcome
Timeframe: Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)Population: The PK Evaluable Population included all participants who enrolled, received at least 1 dose of CC-90011, and had at least 1 measurable concentration of CC-90011. Only participants with data available at the specified timepoints are included in the analysis. Prespecified to be reported for Part A only.
Blood samples were collected to assess Cmax. Prespecified to be reported for Part A only.
Outcome measures
| Measure |
Part A 1.25 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
|
Part A 2.5 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
|
Part A 5 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
|
Part A 10 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
|
Part A 20 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
|
Part A 40 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
|
Part A 60 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
|
Part A 80 mg
n=10 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
|
Part A 120 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A - Maximum Observed Plasma Concentration (Cmax) of CC-90011
Cycle 1 Day 1
|
0.4077 ng/mL
Geometric Coefficient of Variation 35.18
|
0.8042 ng/mL
Geometric Coefficient of Variation 46.38
|
1.520 ng/mL
Geometric Coefficient of Variation 39.99
|
2.514 ng/mL
Geometric Coefficient of Variation 32.41
|
4.526 ng/mL
Geometric Coefficient of Variation 75.80
|
16.28 ng/mL
Geometric Coefficient of Variation 40.03
|
23.02 ng/mL
Geometric Coefficient of Variation 55.31
|
23.66 ng/mL
Geometric Coefficient of Variation 37.60
|
42.03 ng/mL
Geometric Coefficient of Variation 45.99
|
|
Part A - Maximum Observed Plasma Concentration (Cmax) of CC-90011
Cycle Day 22
|
0.4181 ng/mL
Geometric Coefficient of Variation 48.30
|
0.7708 ng/mL
Geometric Coefficient of Variation 42.21
|
1.651 ng/mL
Geometric Coefficient of Variation 45.37
|
3.886 ng/mL
Geometric Coefficient of Variation 28.94
|
6.924 ng/mL
Geometric Coefficient of Variation 62.53
|
10.85 ng/mL
Geometric Coefficient of Variation 29.33
|
20.43 ng/mL
Geometric Coefficient of Variation 51.67
|
25.26 ng/mL
Geometric Coefficient of Variation 62.11
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)Population: The PK Evaluable Population included all participants who enrolled, received at least 1 dose of CC-90011, and had at least 1 measurable concentration of CC-90011. Only participants with data available at the specified timepoints are included in the analysis.
Blood samples were collected to assess AUCt. Prespecified to be reported for Part A only.
Outcome measures
| Measure |
Part A 1.25 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
|
Part A 2.5 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
|
Part A 5 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
|
Part A 10 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
|
Part A 20 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
|
Part A 40 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
|
Part A 60 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
|
Part A 80 mg
n=10 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
|
Part A 120 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A - Area Under the Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUCt) of CC-90011
Cycle 1 Day 1
|
5.806 h*ng/mL
Geometric Coefficient of Variation 55.98
|
24.47 h*ng/mL
Geometric Coefficient of Variation 76.85
|
44.77 h*ng/mL
Geometric Coefficient of Variation 35.77
|
103.07 h*ng/mL
Geometric Coefficient of Variation 42.47
|
179.48 h*ng/mL
Geometric Coefficient of Variation 136.69
|
551.55 h*ng/mL
Geometric Coefficient of Variation 19.29
|
704.82 h*ng/mL
Geometric Coefficient of Variation 60.95
|
849.47 h*ng/mL
Geometric Coefficient of Variation 45.94
|
1736.85 h*ng/mL
Geometric Coefficient of Variation 25.11
|
|
Part A - Area Under the Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUCt) of CC-90011
Cycle Day 22
|
11.48 h*ng/mL
Geometric Coefficient of Variation 40.94
|
23.54 h*ng/mL
Geometric Coefficient of Variation 25.12
|
45.30 h*ng/mL
Geometric Coefficient of Variation 46.78
|
125.53 h*ng/mL
Geometric Coefficient of Variation 8.738
|
237.12 h*ng/mL
Geometric Coefficient of Variation 83.11
|
337.92 h*ng/mL
Geometric Coefficient of Variation 30.72
|
625.53 h*ng/mL
Geometric Coefficient of Variation 24.73
|
654.76 h*ng/mL
Geometric Coefficient of Variation 55.42
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)Population: The PK Evaluable Population included all participants who enrolled, received at least 1 dose of CC-90011, and had at least 1 measurable concentration of CC-90011. Only participants with data available at the specified timepoints are included in the analysis.
Blood samples were collected to assess Tmax. Prespecified to be reported for Part A only.
Outcome measures
| Measure |
Part A 1.25 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
|
Part A 2.5 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
|
Part A 5 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
|
Part A 10 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
|
Part A 20 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
|
Part A 40 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
|
Part A 60 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
|
Part A 80 mg
n=10 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
|
Part A 120 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A - Time to Cmax (Tmax) of CC-90011
Cycle Day 22
|
2.008 hours
Interval 1.95 to 4.067
|
2.992 hours
Interval 1.983 to 4.017
|
3.917 hours
Interval 1.983 to 4.067
|
4.000 hours
Interval 3.833 to 4.167
|
4.567 hours
Interval 2.0 to 6.0
|
4.067 hours
Interval 4.0 to 6.0
|
3.950 hours
Interval 1.867 to 6.0
|
2.083 hours
Interval 2.0 to 6.0
|
—
|
|
Part A - Time to Cmax (Tmax) of CC-90011
Cycle 1 Day 1
|
2.083 hours
Interval 2.05 to 4.0
|
2.017 hours
Interval 2.0 to 4.083
|
4.042 hours
Interval 2.0 to 4.133
|
2.000 hours
Interval 1.917 to 2.0
|
4.183 hours
Interval 4.017 to 6.133
|
4.117 hours
Interval 2.0 to 8.067
|
4.075 hours
Interval 4.0 to 6.0
|
4.042 hours
Interval 3.95 to 6.0
|
3.242 hours
Interval 2.083 to 6.0
|
SECONDARY outcome
Timeframe: Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)Population: The PK Evaluable Population included all participants who enrolled, received at least 1 dose of CC-90011, and had at least 1 measurable concentration of CC-90011. Only participants with data available at the specified timepoints are included in the analysis.
Blood samples were collected to assess CL/F. Prespecified to be reported for Part A only.
Outcome measures
| Measure |
Part A 1.25 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
|
Part A 2.5 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
|
Part A 5 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
|
Part A 10 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
|
Part A 20 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
|
Part A 40 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
|
Part A 60 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
|
Part A 80 mg
n=10 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
|
Part A 120 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A - Half-life (t1/2) of CC-90011
Cycle 1 Day 1
|
34.33 hour
Interval 20.93 to 66.63
|
73.07 hour
Interval 41.84 to 83.7
|
79.30 hour
Interval 28.86 to 108.39
|
70.54 hour
Interval 51.66 to 94.99
|
68.35 hour
Interval 48.87 to 105.32
|
59.82 hour
Interval 48.34 to 72.33
|
63.88 hour
Interval 50.57 to 90.4
|
58.52 hour
Interval 46.48 to 79.08
|
67.33 hour
Interval 61.17 to 75.06
|
|
Part A - Half-life (t1/2) of CC-90011
Cycle Day 22
|
77.27 hour
Interval 76.35 to 88.38
|
73.25 hour
Interval 67.3 to 96.45
|
53.62 hour
Interval 25.83 to 82.82
|
72.52 hour
Interval 62.75 to 73.84
|
55.76 hour
Interval 44.35 to 139.08
|
71.88 hour
Interval 41.58 to 92.17
|
61.03 hour
Interval 50.61 to 81.1
|
56.03 hour
Interval 30.47 to 86.98
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)Population: The PK Evaluable Population included all participants who enrolled, received at least 1 dose of CC-90011, and had at least 1 measurable concentration of CC-90011. Only participants with data available at the specified timepoints are included in the analysis.
Blood samples were collected to assess CL/F. Prespecified to be reported for Part A only.
Outcome measures
| Measure |
Part A 1.25 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
|
Part A 2.5 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
|
Part A 5 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
|
Part A 10 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
|
Part A 20 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
|
Part A 40 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
|
Part A 60 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
|
Part A 80 mg
n=10 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
|
Part A 120 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A - Apparent Clearance (CL/F) of CC-90011
Cycle 1 Day 1
|
—
|
35.61 Litres per hours
Geometric Coefficient of Variation NA
Not calculated due to 1 participant analyzed.
|
95.70 Litres per hours
Geometric Coefficient of Variation 20.82
|
80.08 Litres per hours
Geometric Coefficient of Variation 44.68
|
64.69 Litres per hours
Geometric Coefficient of Variation 79.21
|
63.23 Litres per hours
Geometric Coefficient of Variation 23.92
|
73.37 Litres per hours
Geometric Coefficient of Variation 65.85
|
81.99 Litres per hours
Geometric Coefficient of Variation 50.36
|
57.51 Litres per hours
Geometric Coefficient of Variation 27.62
|
SECONDARY outcome
Timeframe: Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)Population: The PK Evaluable Population included all participants who enrolled, received at least 1 dose of CC-90011, and had at least 1 measurable concentration of CC-90011. Only participants with data available at the specified timepoints are included in the analysis.
Blood samples were collected to assess Vz/F. Prespecified to be reported for Part A only.
Outcome measures
| Measure |
Part A 1.25 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
|
Part A 2.5 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
|
Part A 5 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
|
Part A 10 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
|
Part A 20 mg
n=5 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
|
Part A 40 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
|
Part A 60 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
|
Part A 80 mg
n=10 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
|
Part A 120 mg
n=4 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A- Volume of Distribution (Vz/F) of CC-90011
Cycle 1 Day 1
|
—
|
3400.66 Litre
Geometric Coefficient of Variation NA
Not calculated due to 1 participant analyzed.
|
7814.20 Litre
Geometric Coefficient of Variation 50.12
|
8076.70 Litre
Geometric Coefficient of Variation 44.02
|
5734.70 Litre
Geometric Coefficient of Variation 64.00
|
5506.05 Litre
Geometric Coefficient of Variation 20.02
|
7245.99 Litre
Geometric Coefficient of Variation 73.93
|
6984.46 Litre
Geometric Coefficient of Variation 37.88
|
5598.55 Litre
Geometric Coefficient of Variation 19.95
|
SECONDARY outcome
Timeframe: From first dose (Day 1) until disease progression or death due to any cause (up to 720 days)Population: The Treated Population included all participants who enrolled and received at least 1 dose of CC-90011. Prespecified to be reported for Part B only
The Clinical Benefit Rate (CBR) is defined as tumor responses (as assessed by the Investigators) of CR, PR and durable SD (SD of ≥ 4 months duration). Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \\\>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Stable Disease (SD) is concluded when the response does not qualify for CR, PR or Progression. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
Outcome measures
| Measure |
Part A 1.25 mg
n=14 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
|
Part A 2.5 mg
n=2 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
|
Part A 5 mg
n=3 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
|
Part A 10 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
|
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
|
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
|
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
|
Part A 80 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
|
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B - Clinical Benefit Rate (CBR) as Per Confirmed Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST 1.1)
|
50.0 percentage of participants
Interval 23.0 to 77.0
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
0.0 percentage of participants
Interval 0.0 to 70.8
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose (Day 1) till disease progression or death due to any cause (up to 720 days)Population: The Treated Population included all participants who enrolled and received at least 1 dose of CC-90011. Prespecified to be reported for Part B only.
The Objective Response Rate (ORR) is defined as the percent of participants whose best response is CR or PR. Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \\\>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
Outcome measures
| Measure |
Part A 1.25 mg
n=14 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
|
Part A 2.5 mg
n=2 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
|
Part A 5 mg
n=3 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
|
Part A 10 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
|
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
|
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
|
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
|
Part A 80 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
|
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B - Objective Response Rate as Per Confirmed Best Overall Response Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST 1.1)
|
0.0 percentage of participants
Interval 0.0 to 23.2
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
0.0 percentage of participants
Interval 0.0 to 70.8
|
0.0 percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose (Day 1) until disease progression or death due to any cause (up to 720 days)Population: The Treated Population included all participants who enrolled and received at least 1 dose of CC-90011. Treated Population with Confirmed Best Response of CR or PR. Prespecified to be reported for Part B only.
Duration of response is measured from the time when criteria for CR/PR are first met (whichever is first recorded) until the first date at which progressive disease is objectively documented. Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \\\>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose (Day 1) until disease progression or death due to any cause (up to 720 days)Population: The Treated Population included all participants who enrolled and received at least 1 dose of CC-90011. Prespecified to be reported for Part B only
Progression-Free Survival (PFS) is defined as the time from the first dose of CC-90011 to the first occurrence of disease progression or death from any cause based on Kaplan-Meier methodology Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
Outcome measures
| Measure |
Part A 1.25 mg
n=14 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
|
Part A 2.5 mg
n=2 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
|
Part A 5 mg
n=3 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
|
Part A 10 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
|
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
|
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
|
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
|
Part A 80 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
|
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B - Progression Free Survival (PFS)
|
140.5 days
Interval 51.0 to 176.0
|
38.0 days
Interval 24.0 to
UL of 95% CI not estimated due to insufficient number of events.
|
28.0 days
Interval 22.0 to
UL of 95% CI not estimated due to insufficient number of events.
|
81.5 days
Interval 26.0 to
UL of 95% CI not estimated due to insufficient number of events.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose (Day 1) until death due to any cause (up to 720 days)Population: The Treated Population included all participants who enrolled and received at least 1 dose of CC-90011. Prespecified to be reported for Part B only.
Overall Survival (OS) is defined as the time from the first dose of study drug to death due to any cause based on Kaplan-Meier methodology.
Outcome measures
| Measure |
Part A 1.25 mg
n=14 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
|
Part A 2.5 mg
n=2 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
|
Part A 5 mg
n=3 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
|
Part A 10 mg
n=6 Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
|
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
|
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
|
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
|
Part A 80 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
|
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B - Overall Survival (OS)
|
720.0 days
Interval 73.0 to
UL of 95% CI not estimated due to insufficient number of events.
|
307.0 days
Interval 214.0 to
UL of 95% CI not estimated due to insufficient number of events.
|
NA days
Interval 147.0 to
Median and UL of 95% CI not estimated due to insufficient number of events.
|
180.0 days
Interval 156.0 to
UL of 95% CI not estimated due to insufficient number of events.
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A 1.25 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 4 deaths
Part A 2.5 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 4 deaths
Part A 5 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 3 deaths
Part A 10 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 4 deaths
Part A 20 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 2 deaths
Part A 40 mg
Serious events: 5 serious events
Other events: 6 other events
Deaths: 3 deaths
Part A 60 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 5 deaths
Part A 80 mg
Serious events: 6 serious events
Other events: 10 other events
Deaths: 7 deaths
Part A 120 mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 3 deaths
Part B 60 mg
Serious events: 7 serious events
Other events: 25 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Part A 1.25 mg
n=4 participants at risk
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received CC-90011 capsule orally once per week of different doses.
|
Part A 2.5 mg
n=5 participants at risk
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
|
Part A 5 mg
n=6 participants at risk
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
|
Part A 10 mg
n=4 participants at risk
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
|
Part A 20 mg
n=5 participants at risk
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
|
Part A 40 mg
n=6 participants at risk
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
|
Part A 60 mg
n=6 participants at risk
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
|
Part A 80 mg
n=10 participants at risk
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
|
Part A 120 mg
n=4 participants at risk
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
|
Part B 60 mg
n=25 participants at risk
Participants with Lung NETs, or NEPC, or MZL received 60 mg of CC-90011 capsule orally once per week.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
50.0%
2/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
8.0%
2/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
General disorders
Chest pain
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
General disorders
Fatigue
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Infections and infestations
Cystitis
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
Other adverse events
| Measure |
Part A 1.25 mg
n=4 participants at risk
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received CC-90011 capsule orally once per week of different doses.
|
Part A 2.5 mg
n=5 participants at risk
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
|
Part A 5 mg
n=6 participants at risk
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
|
Part A 10 mg
n=4 participants at risk
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
|
Part A 20 mg
n=5 participants at risk
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
|
Part A 40 mg
n=6 participants at risk
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
|
Part A 60 mg
n=6 participants at risk
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
|
Part A 80 mg
n=10 participants at risk
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
|
Part A 120 mg
n=4 participants at risk
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
|
Part B 60 mg
n=25 participants at risk
Participants with Lung NETs, or NEPC, or MZL received 60 mg of CC-90011 capsule orally once per week.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
75.0%
3/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
66.7%
4/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
2/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
32.0%
8/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
24.0%
6/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
2/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
75.0%
3/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
32.0%
8/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
60.0%
3/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
66.7%
4/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
66.7%
4/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
70.0%
7/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
100.0%
4/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
64.0%
16/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
33.3%
2/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Endocrine disorders
Cushing's syndrome
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
2/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
33.3%
2/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
2/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
50.0%
3/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
50.0%
3/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
28.0%
7/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
33.3%
2/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
40.0%
2/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
30.0%
3/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
50.0%
2/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
24.0%
6/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Dyspepsia
|
50.0%
2/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
2/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
40.0%
2/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
33.3%
2/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
33.3%
2/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
36.0%
9/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
8.0%
2/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
60.0%
3/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
66.7%
4/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.0%
4/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
General disorders
Asthenia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
40.0%
2/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
75.0%
3/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
2/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
32.0%
8/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
General disorders
Catheter site pain
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
General disorders
Fatigue
|
50.0%
2/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
60.0%
3/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
30.0%
3/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
50.0%
2/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
8.0%
2/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
General disorders
Hyperthermia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
General disorders
Influenza like illness
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
General disorders
Non-cardiac chest pain
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
General disorders
Pain
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
General disorders
Pyrexia
|
50.0%
2/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
33.3%
2/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
8.0%
2/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
8.0%
2/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Infections and infestations
Ear infection
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Infections and infestations
Nail infection
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
33.3%
2/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
33.3%
2/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
2/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Investigations
Amylase increased
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
8.0%
2/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
33.3%
2/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
33.3%
2/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
2/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
12.0%
3/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
8.0%
2/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Investigations
Lipase increased
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.0%
4/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
50.0%
2/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
40.0%
2/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
33.3%
2/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.0%
4/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
40.0%
2/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
2/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
12.0%
3/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
33.3%
2/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
2/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
50.0%
2/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
5/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
30.0%
3/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
8.0%
2/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
12.0%
3/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
8.0%
2/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
8.0%
2/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
8.0%
2/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
12.0%
3/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
2/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.0%
4/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
33.3%
2/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
8.0%
2/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Nervous system disorders
Hypoglossal nerve disorder
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
8.0%
2/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
8.0%
2/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Psychiatric disorders
Confusional state
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
8.0%
2/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
2/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
12.0%
3/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
8.0%
2/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
33.3%
2/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.0%
4/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
12.0%
3/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
2/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
12.0%
3/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
8.0%
2/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
8.0%
2/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
8.0%
2/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
10.0%
1/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
1/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
4.0%
1/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
20.0%
2/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
25.0%
1/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
16.7%
1/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/5 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/6 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/10 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/4 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
0.00%
0/25 • All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER