Trial Outcomes & Findings for Study Of PF-06817024 In Healthy Subjects, In Patients With Chronic Rhinosinusitis With Nasal Polyps And in Patients With Atopic Dermatitis (NCT NCT02743871)
NCT ID: NCT02743871
Last Updated: 2022-05-19
Results Overview
An adverse event (AE) was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.
COMPLETED
PHASE1
97 participants
From Study Day 1 (baseline) up to Day 421 (Cohort 1 and 2), Day 601 (Cohort 3), Day 691 (Cohort 4), Day 781 (Cohort 5), and Day 511 (Cohort 7).
2022-05-19
Participant Flow
A total of 97 participants were assigned and treated in this study, with 49, 20, and 28 participants in Part 1, 2, and 3, respectively.
Participant milestones
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg Intravenously (IV) Single Dose (SD)
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 7: PF-06817024 30 mg Subcutaneously (SC) SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV Multiple Doses (MD)
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
Part 2 Cohort 8: PF-06817024 300 mg IV Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Participants with chronic rhinosinusitis with nasal polyps (CRSwNP) received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 2 Cohort 8: Placebo IV CRSwNP
Participants with CRSwNP received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV Atopic Dermatitis (AD)
Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85.
|
Part 3 Cohort 13: Placebo IV AD
Participants with moderate to severe AD received the matching placebo of PF-06817024 IV on Study Days 1, 29, 57, and 85.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
3
|
4
|
6
|
6
|
8
|
2
|
2
|
11
|
9
|
20
|
8
|
|
Overall Study
COMPLETED
|
5
|
6
|
6
|
2
|
4
|
6
|
5
|
8
|
2
|
2
|
10
|
6
|
5
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
3
|
15
|
7
|
Reasons for withdrawal
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg Intravenously (IV) Single Dose (SD)
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 7: PF-06817024 30 mg Subcutaneously (SC) SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV Multiple Doses (MD)
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
Part 2 Cohort 8: PF-06817024 300 mg IV Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Participants with chronic rhinosinusitis with nasal polyps (CRSwNP) received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 2 Cohort 8: Placebo IV CRSwNP
Participants with CRSwNP received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV Atopic Dermatitis (AD)
Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85.
|
Part 3 Cohort 13: Placebo IV AD
Participants with moderate to severe AD received the matching placebo of PF-06817024 IV on Study Days 1, 29, 57, and 85.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
12
|
6
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Study Of PF-06817024 In Healthy Subjects, In Patients With Chronic Rhinosinusitis With Nasal Polyps And in Patients With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 7: PF-06817024 30 mg SC SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
n=3 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
n=4 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
n=8 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
n=2 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
n=2 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP
n=11 Participants
Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 2 Cohort 8: Placebo IV CRSwNP
n=9 Participants
Participants with CRSwNP received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD
n=20 Participants
Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85.
|
Part 3 Cohort 13: Placebo IV AD
n=8 Participants
Participants with moderate to severe AD received the matching placebo of PF-06817024 IV on Study Days 1, 29, 57, and 85.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.0 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
37.0 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
43.2 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
27.0 years
STANDARD_DEVIATION 6.1 • n=4 Participants
|
26.5 years
STANDARD_DEVIATION 6.8 • n=21 Participants
|
36.3 years
STANDARD_DEVIATION 7.7 • n=8 Participants
|
39.8 years
STANDARD_DEVIATION 8.7 • n=8 Participants
|
33.3 years
STANDARD_DEVIATION 12.0 • n=24 Participants
|
23.5 years
STANDARD_DEVIATION 0.7 • n=42 Participants
|
34.5 years
STANDARD_DEVIATION 4.9 • n=42 Participants
|
54.4 years
STANDARD_DEVIATION 6.2 • n=42 Participants
|
42.8 years
STANDARD_DEVIATION 10.7 • n=42 Participants
|
38.9 years
STANDARD_DEVIATION 13.8 • n=36 Participants
|
41.0 years
STANDARD_DEVIATION 17.4 • n=36 Participants
|
49.2 years
STANDARD_DEVIATION 10.2 • n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
7 Participants
n=36 Participants
|
29 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
68 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
44 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
9 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
37 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
12 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: From Study Day 1 (baseline) up to Day 421 (Cohort 1 and 2), Day 601 (Cohort 3), Day 691 (Cohort 4), Day 781 (Cohort 5), and Day 511 (Cohort 7).Population: All participants who received at least 1 dose of study medication.
An adverse event (AE) was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
n=3 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
n=4 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
n=8 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
n=2 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
n=2 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With All-causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part 1
Number of Participants With All-Causality SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With All-causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part 1
Number of Participants With All-Causality TEAEs
|
6 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
4 Participants
|
8 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From Study Day 1 (baseline) up to Day 421 (Cohort 1 and 2), Day 601 (Cohort 3), Day 691 (Cohort 4), Day 781 (Cohort 5), and Day 511 (Cohort 7).Population: All participants who received at least 1 dose of study medication.
An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. The causality of TEAEs and SAEs was determined by the investigator.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
n=3 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
n=4 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
n=8 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
n=2 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
n=2 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Related TEAEs and SAEs in Part 1
Number of Participants With Treatment-Related TEAEs
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Related TEAEs and SAEs in Part 1
Number of Participants With Treatment-Related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Study Day 1 (baseline) up to Day 421 (Cohort 1 and 2), Day 601 (Cohort 3), Day 691 (Cohort 4), Day 781 (Cohort 5), and Day 511 (Cohort 7).Population: All participants who received at least 1 dose of study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. TEAE was assessed by the investigator according to severity; Mild: did not interfere with participant's usual function; moderate: interfered to some extent with participant's usual function; severe: interfered significantly with participant's usual function.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
n=3 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
n=4 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
n=8 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
n=2 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
n=2 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of All-Causality TEAEs According to Severity in Part 1
Mild
|
14 Events
|
10 Events
|
20 Events
|
11 Events
|
4 Events
|
15 Events
|
10 Events
|
30 Events
|
3 Events
|
4 Events
|
|
Number of All-Causality TEAEs According to Severity in Part 1
Moderate
|
2 Events
|
2 Events
|
1 Events
|
0 Events
|
0 Events
|
2 Events
|
1 Events
|
2 Events
|
0 Events
|
0 Events
|
|
Number of All-Causality TEAEs According to Severity in Part 1
Severe
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
PRIMARY outcome
Timeframe: From Study Day 1 (baseline) up to Day 421 (Cohort 1 and 2), Day 601 (Cohort 3), Day 691 (Cohort 4), Day 781 (Cohort 5), and Day 511 (Cohort 7).Population: All participants who received at least 1 dose of study medication.
An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
n=3 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
n=4 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
n=8 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
n=2 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
n=2 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Permanent Discontinuation Due to TEAEs in Part 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Study Day 1 (baseline) up to Day 691.Population: All participants who received at least 1 dose of study medication.
An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=11 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=9 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With All-Causality TEAEs and SAEs in Part 2
Number of Participants With All-Causality TEAEs
|
10 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With All-Causality TEAEs and SAEs in Part 2
Number of Participants With All-Causality SAEs
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Study Day 1 (baseline) up to Day 691.Population: All participants who received at least 1 dose of study medication.
An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. The causality of TEAEs and SAEs was determined by the investigator.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=11 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=9 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Related TEAEs and SAEs in Part 2
Number of Participants With Treatment-Related TEAEs
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Related TEAEs and SAEs in Part 2
Number of Participants With Treatment-Related SAEs
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Study Day 1 (baseline) up to Day 691.Population: All participants who received at least 1 dose of study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. TEAE was assessed by the investigator according to severity; Mild: did not interfere with participant's usual function; moderate: interfered to some extent with participant's usual function; severe: interfered significantly with participant's usual function.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=11 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=9 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of All-Causality TEAEs According to Severity in Part 2
Mild
|
44 Events
|
24 Events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of All-Causality TEAEs According to Severity in Part 2
Moderate
|
14 Events
|
9 Events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of All-Causality TEAEs According to Severity in Part 2
Severe
|
0 Events
|
3 Events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Study Day 1 (baseline) up to Day 691.Population: All participants who received at least 1 dose of study medication.
An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=11 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=9 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Permanent Discontinuation Due to TEAEs in Part 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Study Day 1 (baseline) up to Day 1105.Population: All participants who received at least 1 dose of study medication.
An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=20 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=8 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With All-Causality TEAEs and SAEs in Part 3
Number of Participants With All-Causality TEAEs
|
12 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With All-Causality TEAEs and SAEs in Part 3
Number of Participants With All-Causality SAEs
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Study Day 1 (baseline) up to Day 1105.Population: All participants who received at least 1 dose of study medication.
An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. The causality of TEAEs and SAEs was determined by the investigator.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=20 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=8 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Related TEAEs and SAEs in Part 3
Number of Participants With Treatment-Related TEAEs
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Related TEAEs and SAEs in Part 3
Number of Participants With Treatment-Related SAEs
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Study Day 1 (baseline) up to Day 1105.Population: All participants who received at least 1 dose of study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. TEAE was assessed by the investigator according to severity; Mild: did not interfere with participant's usual function; moderate: interfered to some extent with participant's usual function; severe: interfered significantly with participant's usual function.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=20 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=8 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of All-Causality TEAEs According to Severity in Part 3
Severe
|
13 TEAEs
|
1 TEAEs
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of All-Causality TEAEs According to Severity in Part 3
Mild
|
12 TEAEs
|
2 TEAEs
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of All-Causality TEAEs According to Severity in Part 3
Moderate
|
15 TEAEs
|
5 TEAEs
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Study Day 1 (baseline) up to Day 1105.Population: All participants who received at least 1 dose of study medication.
An AE was any untoward medical occurrence in a clinical investigation participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=20 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=8 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Permanent Discontinuation Due to TEAEs in Part 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Part 1 single-dose cohorts: from Study Day 1 (baseline) up to Day 211. Part 1 multiple-dose cohorts: from Study Day 1 (baseline) up to Day 241.Population: All participants who received at least 1 dose of study medication.
Hematology parameters included hemoglobin, hematocrit, red blood cell, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. Chemistry parameters included blood urea nitrogen, glucose (fasting), calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein. Urine parameters included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy. Clinical significance was judged by the investigator and those met the criteria of AE are listed here. Clinically significant laboratory abnormalities reported for at least 1 participant in the whole study are presented here.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
n=3 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
n=4 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
n=8 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
n=2 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
n=2 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis in Part 1
Blood creatine phosphokinase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis in Part 1
Transaminases increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part 2: from Study Day 1 (baseline) up to Day 211.Population: All participants who received at least 1 dose of study medication.
Hematology parameters included hemoglobin, hematocrit, red blood cell, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. Chemistry parameters included blood urea nitrogen, glucose (fasting), calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein. Urine parameters included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy. Clinical significance was judged by the investigator and those met the criteria of AE are listed here. Clinically significant laboratory abnormalities reported for at least 1 participant in the whole study are presented here.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=11 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=9 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis in Part 2
Transaminases increased
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis in Part 2
Blood creatine phosphokinase increased
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Part 3: from Study Day 1 (baseline) up to Day 966.Population: All participants who received at least 1 dose of study medication.
Hematology parameters included hemoglobin, hematocrit, red blood cell, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. Chemistry parameters included blood urea nitrogen, glucose (fasting), calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein. Urine parameters included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy. Clinical significance was judged by the investigator and those met the criteria of AE are listed here. Clinically significant laboratory abnormalities reported for at least 1 participant in the whole study are presented here.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=20 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=8 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis in Part 3
Transaminases increased
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis in Part 3
Blood creatine phosphokinase increased
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Study Day 1 (baseline) up to end of study (Study Day 211 for Part 1 SD cohorts, and Study Day 241 for Part 1 MD cohorts).Population: All participants who received at least 1 dose of study medication.
Criteria for abnormality in vital signs: supine pulse rate \<40 beats per minute (bpm) or \>120 bpm; supine diastolic blood pressure (DBP) \<50 mmHg, maximum increase or decrease from baseline of \>=20 mmHg; supine systolic blood pressure (SBP) \<90 mmHg, maximum increase or decrease from baseline of \>=30 mmHg. Baseline was defined as the last measurement prior to the first dosing. Vital sign abnormalities reported for at least 1 participant are presented here.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
n=3 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
n=4 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
n=8 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
n=2 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
n=2 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Sign Abnormalities in Part 1
Maximum Increase from Baseline in Supine SBP >= 30 mmHg
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Abnormalities in Part 1
Maximum Decrease from Baseline in Supine DBP >= 20 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Vital Sign Abnormalities in Part 1
Supine SBP <90 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Sign Abnormalities in Part 1
Supine DBP <50 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Sign Abnormalities in Part 1
Maximum Increase from Baseline in Supine DBP >= 20 mmHg
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Abnormalities in Part 1
Maximum Decrease from Baseline in Supine SBP >= 30 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Study Day 1 (baseline) up to end of study (Study Day 211).Population: All participants who received at least 1 dose of study medication.
Criteria for abnormality in vital signs: supine pulse rate \<40 bpm or \>120 bpm; supine DBP \<50 mmHg, maximum increase or decrease from baseline of \>=20 mmHg; supine SBP \<90 mmHg, maximum increase or decrease from baseline of \>=30 mmHg. Baseline was defined as the last measurement prior to the first dosing. Vital sign abnormalities reported for at least 1 participant are presented here.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=11 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=9 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Sign Abnormalities in Part 2
Supine SBP <90 mmHg
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Sign Abnormalities in Part 2
Maximum Increase from Baseline in Supine SBP >= 30 mmHg
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Sign Abnormalities in Part 2
Maximum Decrease from Baseline in Supine SBP >= 30 mmHg
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Study Day 1 (baseline) up to end of study (Study Day 337).Population: All participants who received at least 1 dose of study medication.
Criteria for abnormality in vital signs: supine pulse rate \<40 bpm or \>120 bpm; supine DBP \<50 mmHg, maximum increase or decrease from baseline of \>=20 mmHg; supine SBP \<90 mmHg, maximum increase or decrease from baseline of \>=30 mmHg. Baseline was defined as the last measurement prior to the first dosing. Vital sign abnormalities reported for at least 1 participant are presented here.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=20 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=8 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Sign Abnormalities in Part 3
Maximum Increase from Baseline in Supine SBP >= 30 mmHg
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Sign Abnormalities in Part 3
Maximum Increase from Baseline in Supine DBP >= 20 mmHg
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Sign Abnormalities in Part 3
Supine DBP <50 mmHg
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Sign Abnormalities in Part 3
Maximum Decrease from Baseline in Supine DBP >= 20 mmHg
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Study Day 1 (baseline) up to end of study (Study Day 211 for Part 1 SD cohorts, and Study Day 241 for Part 1 MD cohorts).Population: All participants who received at least 1 dose of study medication.
ECG abnormalities criteria included: 1) maximum QTc interval adjusted according Fridericia formula (QTcF) (msec): 450\<= QTcF \<480, 480\<= QTcF \<500, and QTcF \>=500; QTcF maximum increase from baseline(msec): 30\<= change \<60, and change \>=60; 2) maximum PR interval (msec): \>=300; PR increase from baseline (msec): baseline \>200 with 25% increase at maximum, baseline \<=200 with 50% increase at maximum; 3) maximum QRS (msec): \>=140; QRS increase from baseline (msec) \>=50%. Baseline was defined as the average of the last triplicate measurement prior to the first dosing. ECG abnormalities reported for at least 1 participant are presented here.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
n=3 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
n=4 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
n=8 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
n=2 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
n=2 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities in Part 1
450 <= maximum QTcF interval (msec) <480
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities in Part 1
30 <= maximum QTcF interval increase from baseline (msec) <60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Study Day 1 (baseline) up to end of study (Study Day 211).Population: All participants who received at least 1 dose of study medication.
ECG abnormalities criteria included: 1) maximum QTc interval adjusted according Fridericia formula (QTcF) (msec): 450\<= QTcF \<480, 480\<= QTcF \<500, and QTcF \>=500; QTcF maximum increase from baseline(msec): 30\<= change \<60, and change \>=60; 2) maximum PR interval (msec): \>=300; PR increase from baseline (msec): baseline \>200 with 25% increase at maximum, baseline \<=200 with 50% increase at maximum; 3) maximum QRS (msec): \>=140; QRS increase from baseline (msec) \>=50%. Baseline was defined as the average of the last triplicate measurement prior to the first dosing. ECG abnormalities reported for at least 1 participant are presented here.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=11 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=9 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With ECG Abnormalities in Part 2
450 <= maximum QTcF interval (msec) <480
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ECG Abnormalities in Part 2
30 <= maximum QTcF interval increase from baseline (msec) <60
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Study Day 1 (baseline) up to end of study (Study Day 337).Population: All participants who received at least 1 dose of study medication.
ECG abnormalities criteria included: 1) maximum QTc interval adjusted according Fridericia formula (QTcF) (msec): 450\<= QTcF \<480, 480\<= QTcF \<500, and QTcF \>=500; QTcF maximum increase from baseline(msec): 30\<= change \<60, and change \>=60; 2) maximum PR interval (msec): \>=300; PR increase from baseline (msec): baseline \>200 with 25% increase at maximum, baseline \<=200 with 50% increase at maximum; 3) maximum QRS (msec): \>=140; QRS increase from baseline (msec) \>=50%. Baseline was defined as the average of the last triplicate measurement prior to the first dosing. ECG abnormalities reported for at least 1 participant are presented here.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=20 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=8 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With ECG Abnormalities in Part 3
450 <= maximum QTcF interval (msec) <480
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ECG Abnormalities in Part 3
30 <= maximum QTcF interval increase from baseline (msec) <60
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ECG Abnormalities in Part 3
Maximum QTcF interval increase from baseline (msec) >=60
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ECG Abnormalities in Part 3
Maximum QTcF interval (msec) >=500
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96 hours post dose on Day 1, and on Follow-up Days 8, 15, 32, 46, 61, 91, 121, 151, 181, 211, and at Extended Follow-Up visits (up to a maximum of 780 days/18720 hours post dose).Population: All enrolled participants treated who had at least 1 of the pharmacokinetic (PK) parameters of interest measured.
Maximum observed serum concentration (Cmax) of PF-06817024 following single dose in Part 1; Cmax was defined as the maximum observed serum concentration.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=5 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
n=3 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of PF-06817024 Following Single Dose in Part 1
|
2.879 ug/mL
Geometric Coefficient of Variation 19
|
12.26 ug/mL
Geometric Coefficient of Variation 20
|
2.471 ug/mL
Geometric Coefficient of Variation 43
|
35.56 ug/mL
Geometric Coefficient of Variation 11
|
97.49 ug/mL
Geometric Coefficient of Variation 7
|
313.2 ug/mL
Geometric Coefficient of Variation 17
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Cmax was defined as the maximum observed serum concentration.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=4 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of PF-06817024 Following Multiple Doses in Part 1
Day 1
|
35.35 ug/mL
Geometric Coefficient of Variation 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax of PF-06817024 Following Multiple Doses in Part 1
Day 31
|
NA ug/mL
Geometric Coefficient of Variation NA
Geometric mean is not reported for N\<3.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax of PF-06817024 Following Multiple Doses in Part 1
Day 46
|
41.32 ug/mL
Geometric Coefficient of Variation 11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 8, 12, 24, and 96 hour post dose on Day 1, and Days 8, 15, 32, 61, 91, 121, 181, 211, and at Extended Follow-Up visits (up to a maximum of 690 days/16560 hours post dose).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Cmax was defined as the maximum observed serum concentration.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=11 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of PF-06817024 in Part 2
|
107.1 ug/mL
Geometric Coefficient of Variation 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Cmax was defined as the maximum observed serum concentration.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=20 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of PF-06817024 in Part 3
Day 1
|
197.3 ug/mL
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax of PF-06817024 in Part 3
Day 29
|
165.9 ug/mL
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax of PF-06817024 in Part 3
Day 57
|
190.7 ug/mL
Geometric Coefficient of Variation 39
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax of PF-06817024 in Part 3
Day 85
|
199.8 ug/mL
Geometric Coefficient of Variation 37
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96 hours post dose on Day 1, and on Follow-up Days 8, 15, 32, 46, 61, 91, 121, 151, 181, 211, and at Extended Follow-Up visits (up to a maximum of 780 days/18720 hours post dose).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Cmax(dn) was defined as the dose normalized maximum observed serum concentration, and calculated by Cmax/Dose. Cmax was defined as the maximum observed serum concentration.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=5 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
n=3 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Normalized Maximum Observed Serum Concentration (Cmax[dn]) of PF-06817024 Following Single Dose in Part 1
|
0.2879 ug/mL/mg
Geometric Coefficient of Variation 19
|
0.4091 ug/mL/mg
Geometric Coefficient of Variation 20
|
0.08230 ug/mL/mg
Geometric Coefficient of Variation 43
|
0.3556 ug/mL/mg
Geometric Coefficient of Variation 11
|
0.3249 ug/mL/mg
Geometric Coefficient of Variation 7
|
0.3132 ug/mL/mg
Geometric Coefficient of Variation 17
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Cmax(dn) was defined as dose normalized maximum observed serum concentration, and calculated by Cmax/Dose. Cmax was defined as the maximum observed serum concentration.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=4 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax(dn) of PF-06817024 Following Multiple Doses in Part 1
Day 1
|
0.3535 ug/mL/mg
Geometric Coefficient of Variation 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax(dn) of PF-06817024 Following Multiple Doses in Part 1
Day 31
|
NA ug/mL/mg
Geometric Coefficient of Variation NA
Geometric mean is not reported for N\<3.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax(dn) of PF-06817024 Following Multiple Doses in Part 1
Day 46
|
0.4132 ug/mL/mg
Geometric Coefficient of Variation 11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 8, 12, 24, and 96 hour post dose on Day 1, and Days 8, 15, 32, 61, 91, 121, 181, 211, and at Extended Follow-Up visits (up to a maximum of 690 days/16560 hours post dose).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Cmax(dn) was defined as the dose normalized maximum observed serum concentration, and calculated by Cmax/Dose. Cmax was defined as the maximum observed serum concentration.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=11 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax(dn) of PF-06817024 in Part 2
|
0.3569 ug/mL/mg
Geometric Coefficient of Variation 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Cmax(dn) was defined as the dose normalized maximum observed serum concentration, and calculated by Cmax/Dose. Cmax was defined as the maximum observed serum concentration.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=20 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax(dn) of PF-06817024 in Part 3
Day 1
|
0.3306 ug/mL/mg
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax(dn) of PF-06817024 in Part 3
Day 29
|
0.5544 ug/mL/mg
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax(dn) of PF-06817024 in Part 3
Day 57
|
0.6361 ug/mL/mg
Geometric Coefficient of Variation 39
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax(dn) of PF-06817024 in Part 3
Day 85
|
0.6663 ug/mL/mg
Geometric Coefficient of Variation 37
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96 hours post dose on Day 1, and on Follow-up Days 8, 15, 32, 46, 61, 91, 121, 151, 181, 211, and at Extended Follow-Up visits (up to a maximum of 780 days/18720 hours post dose).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Time to reach maximum observed serum concentration (Tmax) of PF-06817024 in Part 1; Tmax was defined as time to reach maximum observed serum concentration.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=5 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
n=3 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-06817024 Following Single Dose in Part 1
|
4.00 Hours
Interval 1.95 to 4.05
|
1.76 Hours
Interval 1.02 to 2.33
|
338 Hours
Interval 338.0 to 1080.0
|
1.07 Hours
Interval 1.03 to 2.75
|
2.00 Hours
Interval 1.53 to 8.0
|
1.775 Hours
Interval 1.53 to 4.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Tmax was defined as time to reach maximum observed serum concentration.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=4 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of PF-06817024 Following Multiple Doses in Part 1
Day 1
|
2.010 hour
Interval 1.03 to 8.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax of PF-06817024 Following Multiple Doses in Part 1
Day 31
|
NA hour
Geometric mean is not reported for N\<3.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax of PF-06817024 Following Multiple Doses in Part 1
Day 46
|
1.550 hour
Interval 1.53 to 2.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 8, 12, 24, and 96 hour post dose on Day 1, and Days 8, 15, 32, 61, 91, 121, 181, 211, and at Extended Follow-Up visits (up to a maximum of 690 days/16560 hours post dose).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Tmax was defined as time to reach maximum observed serum concentration.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=11 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of PF-06817024 in Part 2
|
2.00 Hours
Interval 1.53 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Tmax was defined as time to reach maximum observed serum concentration.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=20 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of PF-06817024 in Part 3
Day 1
|
2.03 Hours
Interval 1.48 to 5.12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax of PF-06817024 in Part 3
Day 29
|
1.70 Hours
Interval 1.52 to 5.17
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax of PF-06817024 in Part 3
Day 57
|
1.75 Hours
Interval 1.57 to 5.15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax of PF-06817024 in Part 3
Day 85
|
1.76 Hours
Interval 1.5 to 2.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 8, 12, 24, and 96 hour post dose on Day 1, and Days 8, 15, 32, 61, 91, 121, 181, 211, and at Extended Follow-Up visits (up to 780 days for Part 1 and 690 days for Part 2). For Part 1 only: at post-dose 48 and 72 hour, Days 46 and 151.Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Area under the curve from time zero to infinity concentration (AUCinf) of PF-06817024 following single dose in Part 1 and 2; AUCinf was defined as area under the curve from time zero to infinity concentration.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=5 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
n=3 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
n=5 Participants
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
n=11 Participants
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Infinity Concentration (AUCinf) of PF-06817024 Following Single Dose in Part 1 and 2
|
4384 ug*hr/mL
Geometric Coefficient of Variation 28
|
14640 ug*hr/mL
Geometric Coefficient of Variation 28
|
8646 ug*hr/mL
Geometric Coefficient of Variation 38
|
44460 ug*hr/mL
Geometric Coefficient of Variation 22
|
116700 ug*hr/mL
Geometric Coefficient of Variation 23
|
427100 ug*hr/mL
Geometric Coefficient of Variation 10
|
146200 ug*hr/mL
Geometric Coefficient of Variation 19
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 8, 12, 24, and 96 hour post dose on Day 1, and Days 8, 15, 32, 61, 91, 121, 181, 211, and at Extended Follow-Up visits (up to 780 days for Part 1 and 690 days for Part 2). For Part 1 only: at post-dose 48 and 72 hour, Days 46 and 151.Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Area under the curve from time zero to last quantifiable concentration (AUClast) of PF-06817024 following single dose in Part 1 and 2; AUClast was defined as area under the curve from time zero to last quantifiable concentration.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=5 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
n=3 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
n=5 Participants
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
n=11 Participants
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06817024 Following Single Dose in Part 1 and 2
|
4075 ug*hr/mL
Geometric Coefficient of Variation 29
|
14070 ug*hr/mL
Geometric Coefficient of Variation 26
|
8333 ug*hr/mL
Geometric Coefficient of Variation 39
|
43510 ug*hr/mL
Geometric Coefficient of Variation 22
|
116000 ug*hr/mL
Geometric Coefficient of Variation 22
|
425700 ug*hr/mL
Geometric Coefficient of Variation 10
|
143300 ug*hr/mL
Geometric Coefficient of Variation 23
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Area under the curve within dosing interval (AUCtau) of PF-06817024 following multiple doses in Part 1; AUCtau was defined as area under the curve within dosing interval. The dosing interval was 720 hours.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=4 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve Within Dosing Interval (AUCtau) of PF-06817024 Following Multiple Doses in Part 1
Day 1
|
10580 ug*hr/mL
Geometric Coefficient of Variation 11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Curve Within Dosing Interval (AUCtau) of PF-06817024 Following Multiple Doses in Part 1
Day 31
|
NA ug*hr/mL
Geometric Coefficient of Variation NA
Geometric mean is not reported for N\<3.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Curve Within Dosing Interval (AUCtau) of PF-06817024 Following Multiple Doses in Part 1
Day 46
|
16210 ug*hr/mL
Geometric Coefficient of Variation 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
AUCtau was defined as area under the curve within dosing interval. The dosing interval was 672 hours.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=20 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
AUCtau of PF-06817024 in Part 3
Day 1
|
58350 ug*hr/mL
Geometric Coefficient of Variation 31
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCtau of PF-06817024 in Part 3
Day 29
|
77550 ug*hr/mL
Geometric Coefficient of Variation 38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCtau of PF-06817024 in Part 3
Day 57
|
90340 ug*hr/mL
Geometric Coefficient of Variation 42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCtau of PF-06817024 in Part 3
Day 85
|
92230 ug*hr/mL
Geometric Coefficient of Variation 42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Dose normalized area under the curve within dosing interval (AUCtau\[dn\]) of PF-06817024 following multiple doses in Part 1; AUCtau(dn) was defined as dose normalized area under the curve within dosing interval. The dosing interval was 720 hours.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=4 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Normalized Area Under the Curve Within Dosing Interval (AUCtau[dn]) of PF-06817024 Following Multiple Doses in Part 1
Day 1
|
105.8 ug*hr/mL/mg
Geometric Coefficient of Variation 11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Normalized Area Under the Curve Within Dosing Interval (AUCtau[dn]) of PF-06817024 Following Multiple Doses in Part 1
Day 31
|
NA ug*hr/mL/mg
Geometric Coefficient of Variation NA
Geometric mean is not reported for N\<3.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Normalized Area Under the Curve Within Dosing Interval (AUCtau[dn]) of PF-06817024 Following Multiple Doses in Part 1
Day 46
|
162.1 ug*hr/mL/mg
Geometric Coefficient of Variation 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
AUCtau(dn) was defined as dose normalized area under the curve within dosing interval. The dosing interval was 672 hours.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=20 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
AUCtau(dn) of PF-06817024 Following Multiple Doses in Part 3
Day 1
|
97.98 ug*hr/mL/mg
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCtau(dn) of PF-06817024 Following Multiple Doses in Part 3
Day 29
|
259.1 ug*hr/mL/mg
Geometric Coefficient of Variation 38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCtau(dn) of PF-06817024 Following Multiple Doses in Part 3
Day 57
|
301.1 ug*hr/mL/mg
Geometric Coefficient of Variation 42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCtau(dn) of PF-06817024 Following Multiple Doses in Part 3
Day 85
|
307.3 ug*hr/mL/mg
Geometric Coefficient of Variation 42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Average concentration over dosing interval (Cav) of PF-06817024 following multiple doses in Part 1; Cav was defined as average concentration over dosing interval. The dosing interval was 720 hours.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=4 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Average Concentration Over Dosing Interval (Cav) of PF-06817024 Following Multiple Doses in Part 1
Day 1
|
14.70 ug/mL
Geometric Coefficient of Variation 12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Average Concentration Over Dosing Interval (Cav) of PF-06817024 Following Multiple Doses in Part 1
Day 31
|
NA ug/mL
Geometric Coefficient of Variation NA
Geometric mean is not reported for N\<3.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Average Concentration Over Dosing Interval (Cav) of PF-06817024 Following Multiple Doses in Part 1
Day 46
|
22.55 ug/mL
Geometric Coefficient of Variation 16
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Cav was defined as average concentration over dosing interval. The dosing interval was 672 hours.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=20 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cav of PF-06817024 Following Multiple Doses in Part 3
Day 57
|
134.4 ug/mL
Geometric Coefficient of Variation 42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cav of PF-06817024 Following Multiple Doses in Part 3
Day 85
|
137.2 ug/mL
Geometric Coefficient of Variation 42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cav of PF-06817024 Following Multiple Doses in Part 3
Day 1
|
86.78 ug/mL
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cav of PF-06817024 Following Multiple Doses in Part 3
Day 29
|
115.4 ug/mL
Geometric Coefficient of Variation 38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96 hours post dose on Day 1, and on Follow-up Days 8, 15, 32, 46, 61, 91, 121, 151, 181, 211, and at Extended Follow-Up visits (up to a maximum of 780 days/18720 hours post dose).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
t1/2 was defined as terminal elimination half life, and was calculated by Loge(2)/kel, where kel was the terminal elimination phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=5 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
n=3 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
n=5 Participants
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half Life (t1/2) of PF-06817024 Following Single Dose in Part 1
|
91.34 Days
Standard Deviation 14.499
|
88.88 Days
Standard Deviation 15.358
|
97.17 Days
Standard Deviation 11.189
|
83.70 Days
Standard Deviation 32.608
|
83.33 Days
Standard Deviation 20.016
|
93.90 Days
Standard Deviation 5.4749
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
T1/2 of PF-06817024 following multiple doses in Part 1; t1/2 was defined as terminal elimination half life.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=4 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
t1/2 of PF-06817024 Following Multiple Doses in Part 1
Day 31
|
NA Day
Standard Deviation NA
Geometric mean is not reported for N\<3.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
t1/2 of PF-06817024 Following Multiple Doses in Part 1
Day 46
|
98.87 Day
Standard Deviation 5.6083
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 8, 12, 24, and 96 hour post dose on Day 1, and Days 8, 15, 32, 61, 91, 121, 181, 211, and at Extended Follow-Up visits (up to a maximum of 690 days/16560 hours post dose).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
t1/2 was defined as terminal elimination half life, and was calculated by Loge(2)/kel, where kel was the terminal elimination phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=11 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
t1/2 of PF-06817024 in Part 2
|
85.68 Days
Standard Deviation 11.447
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
t1/2 was defined as terminal elimination half life, and was calculated by Loge(2)/kel, where kel was the terminal elimination phase rate constant calculated by a linear regression of the log-linear concentration-time curve. For Part 3 Cohort 13: PF-06817024 600 mg + 300 mg IV AD, t1/2 of the last dose on Day 85 was reported in the table.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=12 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
t1/2 of PF-06817024 in Part 3
|
75.98 Days
Standard Deviation 15.996
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96 hours post dose on Day 1, and on Follow-up Days 8, 15, 32, 46, 61, 91, 121, 151, 181, 211, and at Extended Follow-Up visits (up to a maximum of 780 days/18720 hours post dose).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Apparent volume of distribution (Vz/F) of PF-06817024 for the subcutaneous cohort in Part 1; Vz/F was defined as apparent volume of distribution.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of PF-06817024 for the Subcutaneous Cohort in Part 1
|
11.60 L
Geometric Coefficient of Variation 37
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96 hours post dose on Day 1, and on Follow-up Days 8, 15, 32, 46, 61, 91, 121, 151, 181, 211, and at Extended Follow-Up visits (up to a maximum of 780 days/18720 hours post dose).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Apparent clearance (CL/F) of PF-06817024 for the subcutaneous cohort in Part 1; CL/F was defined as apparent clearance.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of PF-06817024 for the Subcutaneous Cohort in Part 1
|
0.003470 L/hr
Geometric Coefficient of Variation 38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 8, 12, 24, and 96 hour post dose on Day 1, and Days 8, 15, 32, 61, 91, 121, 181, 211, and at Extended Follow-Up visits (up to 780 days for Part 1 and 690 days for Part 2). For Part 1 only: at post-dose 48 and 72 hour, Days 46 and 151.Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Volume of distribution at steady state (Vss) of PF-06817024 following a single dose in Part 1 and Part 2; Vss was defined as volume of distribution at steady state.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=5 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
n=3 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
n=5 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
n=11 Participants
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution at Steady State (Vss) of PF-06817024 Following Single Intravenous Dose in Part 1 and Part 2
|
6.949 L
Geometric Coefficient of Variation 15
|
5.929 L
Geometric Coefficient of Variation 22
|
6.449 L
Geometric Coefficient of Variation 19
|
6.863 L
Geometric Coefficient of Variation 16
|
7.260 L
Geometric Coefficient of Variation 12
|
6.250 L
Geometric Coefficient of Variation 17
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Day 1 at pre-dose, post-dose 1, 2, 4, 8, 12, 24, 96 hour, Day 8, 15, 32, 61, 91, 121,181, 211, 241, 331, and 421. For Part 1 only: at post-dose 48 and 72 hour, Day 46 and 151. For Part 2 only: on Day 511, 601, and 691.Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
CL was defined as Clearance, calculated by Dose/AUCinf. AUCinf was defined as area under the curve from time zero to infinity concentration.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=5 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
n=3 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
n=5 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
n=11 Participants
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Clearance (CL) of PF-06817024 Following Single Intravenous Dose in Part 1 and Part 2
|
0.00228 L/hr
Geometric Coefficient of Variation 28
|
0.00205 L/hr
Geometric Coefficient of Variation 28
|
0.002249 L/hr
Geometric Coefficient of Variation 22
|
0.002574 L/hr
Geometric Coefficient of Variation 23
|
0.002341 L/hr
Geometric Coefficient of Variation 10
|
0.002053 L/hr
Geometric Coefficient of Variation 19
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At pre-dose on Day 31 or Day 46.Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Trough serum concentration (Cmin) of PF-06817024 post second dose following multiple doses in Part 1; Cmin was defined as the trough serum concentration.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=4 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Serum Concentration (Cmin) of PF-06817024 Post Second Dose Following Multiple Doses in Part 1
Day 31
|
NA ug/mL
Geometric Coefficient of Variation NA
Geometric mean is not reported for N\<3.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Serum Concentration (Cmin) of PF-06817024 Post Second Dose Following Multiple Doses in Part 1
Day 46
|
9.851 ug/mL
Geometric Coefficient of Variation 20
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At pre dose (0 hour) on Day 85.Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Cmin of PF-06817024 post last dose following multiple doses in Part 3; Cmin was defined as the trough serum concentration.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=15 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cmin of PF-06817024 Post Last Dose Following Multiple Doses in Part 3
|
81.1 ug/mL
Geometric Coefficient of Variation 51
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Rac, Cmax was defined as accumulation ratio for Cmax, and was calculated by (Cmax on Day 31 or Day 46) / Cmax on Day 1. Cmax was defined as the maximum observed serum concentration.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=4 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio for Cmax (Rac, Cmax) of PF-06817024 Post Second Dose Following Multiple Doses in Part 1
Day 31
|
NA Ratio
Geometric Coefficient of Variation NA
Geometric mean is not reported for N\<3.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Accumulation Ratio for Cmax (Rac, Cmax) of PF-06817024 Post Second Dose Following Multiple Doses in Part 1
Day 46
|
1.106 Ratio
Geometric Coefficient of Variation 3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Rac, Cmax was defined as accumulation ratio for Cmax, and was calculated by (Cmax on Day 85) / (Cmax on Day 1). Cmax was defined as the maximum observed serum concentration.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=16 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Rac, Cmax of PF-06817024 Post Last Dose Following Multiple Doses in Part 3
|
2.005 Ratio
Geometric Coefficient of Variation 24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Rac was defined as accumulation ratio for AUCtau. AUCtau was defined as area under the curve within dosing interval. The dosing interval was 720 hours.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=4 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio for AUCtau (Rac) of PF-06817024 Post Second Dose Following Multiple Doses in Part 1
Day 31
|
NA Ratio
Geometric Coefficient of Variation NA
Geometric mean is not reported for N\<3.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Accumulation Ratio for AUCtau (Rac) of PF-06817024 Post Second Dose Following Multiple Doses in Part 1
Day 46
|
1.499 Ratio
Geometric Coefficient of Variation 10
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85).Population: All enrolled participants treated who had at least 1 of the PK parameters of interest measured.
Rac was defined as accumulation ratio for AUCtau. AUCtau was defined as area under the curve within dosing interval. The dosing interval was 672 hours.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=15 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Rac of PF-06817024 Post Last Dose Following Multiple Doses in Part 3
|
3.163 Ratio
Geometric Coefficient of Variation 20
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1 SD cohorts: baseline up to Day 780; Part 1 MD cohort: baseline up to Day 693; Part 2: baseline up to Day 692, Part 3: baseline up to Day 964.Population: All enrolled participants who received at least 1 dose of investigational product and had at least 1 post-treatment measurement of immunogenicity parameters of interest.
ADA was an immunogenicity endpoint. A participant had treatment-induced ADA when baseline titer was missing or negative and the participant had \>=1 post-treatment positive titer.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
n=3 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
n=4 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
n=11 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
n=20 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Induced Anti-Drug Antibody (ADA) Against PF-06817024 in Part 1, 2, and 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Part 1 SD cohorts: baseline up to Day 780; Part 1 MD cohort: baseline up to Day 693; Part 2: baseline up to Day 692, Part 3: baseline up to Day 964.Population: All enrolled participants who received at least 1 dose of investigational product and had at least 1 post-treatment measurement of immunogenicity parameters of interest.
NAb was an immunogenicity endpoint. A participant had treatment-induced NAb when baseline titer was missing or negative and the participant had \>=1 post-treatment positive titer.
Outcome measures
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 30 mg SC SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
n=3 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
n=4 Participants
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
n=6 Participants
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
n=11 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
n=20 Participants
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Induced Neutralizing Antibodies (NAbs) Against PF-06817024 in Part 1, 2, and 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
Part 1 Cohort 1: PF-06817024 10 mg IV SD
Part 1 Cohort 2: PF-06817024 30 mg IV SD
Part 1 Cohort 7: PF-06817024 30 mg SC SD
Part 1 Cohort 3: PF-06817024 100 mg IV SD
Part 1 Cohort 3: PF-06817024 100 mg IV MD
Part 1 Cohort 4: PF-06817024 300 mg IV SD
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
Part 1: Placebo IV SD
Part 1 Cohort 3: Placebo IV MD
Part 1 Cohort 7: Placebo SC SD
Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP
Part 2 Cohort 8: Placebo IV CRSwNP
Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD
Part 3 Cohort 13: Placebo IV AD
Serious adverse events
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=6 participants at risk
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=6 participants at risk
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 7: PF-06817024 30 mg SC SD
n=6 participants at risk
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
n=3 participants at risk
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
n=4 participants at risk
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
n=6 participants at risk
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
n=6 participants at risk
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
n=8 participants at risk
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
n=2 participants at risk
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
n=2 participants at risk
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP
n=11 participants at risk
Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 2 Cohort 8: Placebo IV CRSwNP
n=9 participants at risk
Participants with CRSwNP received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD
n=20 participants at risk
Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85.
|
Part 3 Cohort 13: Placebo IV AD
n=8 participants at risk
Participants with moderate to severe AD received the matching placebo of PF-06817024 IV on Study Days 1, 29, 57, and 85.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
5.0%
1/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
5.0%
1/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Eczema impetiginous
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenosquamous carcinoma of the cervix
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
5.0%
1/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
5.0%
1/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
Other adverse events
| Measure |
Part 1 Cohort 1: PF-06817024 10 mg IV SD
n=6 participants at risk
Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 2: PF-06817024 30 mg IV SD
n=6 participants at risk
Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 7: PF-06817024 30 mg SC SD
n=6 participants at risk
Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV SD
n=3 participants at risk
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 3: PF-06817024 100 mg IV MD
n=4 participants at risk
Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46).
|
Part 1 Cohort 4: PF-06817024 300 mg IV SD
n=6 participants at risk
Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 1 Cohort 5: PF-06817024 1000 mg IV SD
n=6 participants at risk
Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1.
|
Part 1: Placebo IV SD
n=8 participants at risk
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 1 Cohort 3: Placebo IV MD
n=2 participants at risk
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47).
|
Part 1 Cohort 7: Placebo SC SD
n=2 participants at risk
Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1.
|
Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP
n=11 participants at risk
Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1.
|
Part 2 Cohort 8: Placebo IV CRSwNP
n=9 participants at risk
Participants with CRSwNP received the matching placebo of PF-06817024 IV for a SD on Study Day 1.
|
Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD
n=20 participants at risk
Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85.
|
Part 3 Cohort 13: Placebo IV AD
n=8 participants at risk
Participants with moderate to severe AD received the matching placebo of PF-06817024 IV on Study Days 1, 29, 57, and 85.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
27.3%
3/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
44.4%
4/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
5.0%
1/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Fatigue
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
1/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
50.0%
3/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
3/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
2/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
37.5%
3/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
27.3%
3/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
22.2%
2/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
2/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
18.2%
2/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
2/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
3/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
3/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
2/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
18.2%
2/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
2/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
27.3%
3/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Mouth swelling
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Application site irritation
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Infusion site haemorrhage
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
18.2%
2/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
22.2%
2/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Pain
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Therapeutic response increased
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
27.3%
3/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
36.4%
4/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Post procedural constipation
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
18.2%
2/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Hyposmia
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Psychiatric disorders
Sleep disorder due to general medical condition, insomnia type
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
9.1%
1/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
2/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
37.5%
3/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
10.0%
2/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Chest pain
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Infusion site pain
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Infusion site reaction
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
2/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
1/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Dental restoration failure
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
1/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
1/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
1/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
1/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
1/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Psychiatric disorders
Libido increased
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
1/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
2/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Acne
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
15.0%
3/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
1/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
10.0%
2/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Vascular disorders
Thrombophlebitis
|
16.7%
1/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
10.0%
2/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Conditional aggravated
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Peripheral swelling
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/3 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/4 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/11 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/20 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER