Trial Outcomes & Findings for A Trial of PF-07901800 (TTI-621) for Patients With Hematologic Malignancies and Selected Solid Tumors (NCT NCT02663518)
NCT ID: NCT02663518
Last Updated: 2024-05-10
Results Overview
An adverse event (AE) was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
249 participants
Primary outcome timeframe
Part 1: Day 1 of dosing up to 30 days of safety follow-up visit after the last dose (maximum treatment exposure for Part 1 was 414 days)
Results posted on
2024-05-10
Participant Flow
A total of 249 participants were enrolled in the study.
Participant milestones
| Measure |
Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 milligram per kilogram (mg/kg) infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Ontorpacept (PF-07901800/TTI-621) Monotherapy for Part 2
Participants with a broader variety of hematologic malignancies and selected solid tumors, received a 0.2 mg/kg/week TTI-621 infusion until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with Classical Hodgkin's Lymphoma (cHL) received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 milligram per meter square (mg/m\^2) rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Ontorpacept (PF-07901800/TTI-621) Monotherapy for Part 3
Participants with cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL), received a 0.2 mg/kg/week TTI-621 infusion. Initial 2 weeks of 0.2 mg/kg treatment followed by intraparticipant dose intensification at an increment of 0.1 mg/kg per week up to 0.5 mg/kg within 5-8 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Phase 1a Escalation
STARTED
|
3
|
3
|
7
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Phase 1a Escalation
COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Phase 1a Escalation
NOT COMPLETED
|
3
|
3
|
7
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 and 3: Phase 1b Expansion
STARTED
|
0
|
0
|
0
|
0
|
107
|
11
|
40
|
42
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 and 3: Phase 1b Expansion
COMPLETED
|
0
|
0
|
0
|
0
|
29
|
10
|
6
|
15
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 and 3: Phase 1b Expansion
NOT COMPLETED
|
0
|
0
|
0
|
0
|
78
|
1
|
34
|
27
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 4: Phase 1b Dose Optimization
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
6
|
3
|
12
|
4
|
|
Part 4: Phase 1b Dose Optimization
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
3
|
0
|
4
|
1
|
|
Part 4: Phase 1b Dose Optimization
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
3
|
3
|
8
|
3
|
Reasons for withdrawal
| Measure |
Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 milligram per kilogram (mg/kg) infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Ontorpacept (PF-07901800/TTI-621) Monotherapy for Part 2
Participants with a broader variety of hematologic malignancies and selected solid tumors, received a 0.2 mg/kg/week TTI-621 infusion until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with Classical Hodgkin's Lymphoma (cHL) received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 milligram per meter square (mg/m\^2) rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Ontorpacept (PF-07901800/TTI-621) Monotherapy for Part 3
Participants with cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL), received a 0.2 mg/kg/week TTI-621 infusion. Initial 2 weeks of 0.2 mg/kg treatment followed by intraparticipant dose intensification at an increment of 0.1 mg/kg per week up to 0.5 mg/kg within 5-8 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Phase 1a Escalation
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Phase 1a Escalation
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Phase 1a Escalation
Progressive Disease
|
2
|
3
|
2
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Phase 1a Escalation
Informed Consent Withdrawn
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Phase 1a Escalation
Other
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 and 3: Phase 1b Expansion
Death
|
0
|
0
|
0
|
0
|
50
|
0
|
25
|
16
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 and 3: Phase 1b Expansion
Lost to Follow-up
|
0
|
0
|
0
|
0
|
4
|
0
|
3
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 and 3: Phase 1b Expansion
Progressive Disease
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 and 3: Phase 1b Expansion
Informed Consent Withdrawn
|
0
|
0
|
0
|
0
|
16
|
1
|
3
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 and 3: Phase 1b Expansion
Other
|
0
|
0
|
0
|
0
|
6
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 and 3: Phase 1b Expansion
Study Terminated By Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 4: Phase 1b Dose Optimization
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
5
|
1
|
|
Part 4: Phase 1b Dose Optimization
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part 4: Phase 1b Dose Optimization
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part 4: Phase 1b Dose Optimization
Informed Consent Withdrawn
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
1
|
1
|
|
Part 4: Phase 1b Dose Optimization
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
|
Part 4: Phase 1b Dose Optimization
Study terminated by sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Trial of PF-07901800 (TTI-621) for Patients With Hematologic Malignancies and Selected Solid Tumors
Baseline characteristics by cohort
| Measure |
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg
n=3 Participants
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 milligram per kilogram (mg/kg) infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg
n=3 Participants
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg
n=7 Participants
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg
n=5 Participants
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy
n=107 Participants
Participants with a broader variety of hematologic malignancies and selected solid tumors, received a 0.2 mg/kg/week TTI-621 infusion until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
n=11 Participants
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL.If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
n=40 Participants
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy
n=42 Participants
Participants with CTCL and PTCL, received a 0.2 mg/kg/week TTI-621 infusion. Initial 2 weeks of 0.2 mg/kg treatment followed by intraparticipant dose intensification at an increment of 0.1 mg/kg per week up to 0.5 mg/kg within 5-8 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
n=6 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
n=12 Participants
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
n=4 Participants
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Total
n=249 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
< 65 Years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
20 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
7 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
130 Participants
n=24 Participants
|
|
Age, Customized
65 - < 75 Years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
74 Participants
n=24 Participants
|
|
Age, Customized
75 - < 85 Years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
43 Participants
n=24 Participants
|
|
Age, Customized
>= 85 Years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
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
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
18 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
96 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
30 Participants
n=8 Participants
|
24 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
10 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
153 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
26 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
32 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
209 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
14 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
5 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
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
14 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
28 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
30 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
9 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
191 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
15 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Part 1: Day 1 of dosing up to 30 days of safety follow-up visit after the last dose (maximum treatment exposure for Part 1 was 414 days)Population: Safety population included all the participants who received at least one dose of study treatment.
An adverse event (AE) was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
n=7 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
n=5 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TEAEs
|
—
|
—
|
—
|
—
|
3 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TESAEs
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Part 1: Day 1 of dosing up to Pre-dose on Day 22Population: The DLT-evaluable set included participants who had received all 3 doses within the DLT evaluation period, or participants who experienced an AE, meeting DLT criteria during that time. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
DLT was defined as any of the protocol specified TEAEs that occurred during the 21-day. DLT treatment/observation period (including the pre-dose tests on Day 22/Week 4 Day 1) and that were considered at least possibly related to study treatment by the investigator. Protocol specified DLT TEAE criteria: Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding (with the exception of brief, easily-controlled epistaxis, mild gum bleeding or normal menses) or with any requirement for platelet transfusions; Grade 4 anemia, unexplained by underlying disease; Grade 4 neutropenia lasting more than 5 days; Febrile neutropenia of any duration ( Absolute Neutrophil Count (ANC) less than (\<) 1.0 \* 10\^9/L. fever greater than (\>) 38.5° Degree Celsius (C); Grade 3 or higher non-hematologic toxicity except for alopecia and nausea controlled by medical management; Grade 3 or 4 hemorrhage.
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
n=5 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
n=5 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 of dosing up to 30 days of safety follow-up visit after the last dose (maximum treatment exposure for Part 2 was 1793 days and for Part 3 was 938 days)Population: Analysis population included all the participants who received at least one dose of study treatment.
An AE was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A SAE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=107 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=42 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
n=11 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
n=40 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2 and 3: Number of Participants With TEAEs and TESAEs
TESAEs
|
—
|
—
|
—
|
—
|
43 Participants
|
15 Participants
|
2 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 and 3: Number of Participants With TEAEs and TESAEs
TEAEs
|
—
|
—
|
—
|
—
|
103 Participants
|
40 Participants
|
11 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Part 4: Day 1 of dosing up to 1 year of safety follow-up visit after the last dose (maximum treatment exposure for Part 4 was 667 days)Population: Analysis population included all the participants who received at least one dose of study treatment.
An AE was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A SAE event was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
n=6 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
n=12 Participants
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
n=4 Participants
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 4: Number of Participants With TEAEs and TESAEs
TEAEs
|
—
|
—
|
—
|
—
|
3 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
12 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Part 4: Number of Participants With TEAEs and TESAEs
TESAEs
|
—
|
—
|
—
|
—
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Part 4: Day 1 of dosing up to Pre-dose on Day 22Population: The DLT-evaluable set included participants who had received all 3 doses within the DLT evaluation period, OR participants who experienced an AE, meeting DLT criteria during that time. As 2.0mg/kg Q2W cohort was not a part of escalation for dose optimization, and not relevant to DLT assessment hence this outcome measure was not analyzed for Q2W arm. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
DLT was defined as any of the protocol specified TEAEs that occurred during the 21-day. DLT treatment/observation period (including the pre-dose tests on Day 22/Week 4 Day 1) and that were considered at least possibly related to study treatment by the investigator. Protocol specified DLT TEAE criteria: Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding (with the exception of brief, easily-controlled epistaxis, mild gum bleeding or normal menses) or with any requirement for platelet transfusions; Grade 4 anemia, unexplained by underlying disease; Grade 4 neutropenia lasting more than 5 days; Febrile neutropenia of any duration (ANC \< 1.0 x 109/L, fever \> 38.5°C); Grade 3 or higher non-hematologic toxicity except for alopecia and nausea controlled by medical management; Grade 3 or 4 hemorrhage.
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
n=6 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
n=7 Participants
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 4: Number of Participants With Dose Limiting Toxicities (DLTs)
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1Population: Pharmacokinetic (PK)-evaluable set included treated participants with adequate blood sampling to estimate at least one pharmacokinetic PK parameter.
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
n=7 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
n=5 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Maximum Plasma Concentration (Cmax) of TTI-621
|
—
|
—
|
—
|
—
|
136.594 Nanogram per milliliter
Standard Deviation 64.248
|
366.636 Nanogram per milliliter
Standard Deviation 67.433
|
823.137 Nanogram per milliliter
Standard Deviation 153.681
|
1579.799 Nanogram per milliliter
Standard Deviation 518.546
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1Population: PK evaluable set included treated participants with adequate blood sampling to estimate at least one pharmacokinetic PK parameter. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=1 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=2 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
n=5 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
n=4 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under the Plasma Concentration Time Curve From Time Zero to 168 (AUC[0-168]) of TTI-621
|
—
|
—
|
—
|
—
|
1200.722 Nanogram*hour/milliliter
|
6178.488 Nanogram*hour/milliliter
Standard Deviation 844.463
|
18873.939 Nanogram*hour/milliliter
Standard Deviation 6213.503
|
36782.700 Nanogram*hour/milliliter
Standard Deviation 8700.626
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: Week 1 end of infusion (EOI)Population: This outcome measure was not analyzed since CD47 data for Part 1 was not collected as the assay was not set up when enrolling the Part 1 participants. Hence, no participants evaluable for this outcome measure.
CD47 is a cell-surface protein expressed on multiple normal cell types and often at high levels on many malignant tumour cells .
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Part 1: From pre-infusion on day 1 up to end of study treatment (maximum treatment exposure for Part 1 was 414 days)Population: Immunogenicity analysis population included all treated participants with at least one ADA sample (pre-dose or post-treatment) analyzed. Here, "Number of Participants Analyzed" signifies number of participants who were ADA or NAb evaluable.
A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participants had \>1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \> \[4-fold dilution increase\] in titer from baseline in \>1 post-treatment sample (treatment-boosted).
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
n=7 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
n=4 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb)
ADA Positive: Overall Incidence
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb)
NAb Positive: Overall Incidence
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 2 and 3: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1Population: PK evaluable set included treated participants with adequate blood sampling to estimate at least one PK parameter. Here, "Number of participants analyzed" signifies number of evaluable participants for this outcome measure.
Results for this outcome measure was reported for Part 2 and Part 3 combined.
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=50 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=147 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
n=1 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2 and 3 Combined: Maximum Plasma Concentration (Cmax) of TTI-621
|
—
|
—
|
—
|
—
|
341 Nanogram per milliliter
Standard Deviation 160
|
1020 Nanogram per milliliter
Standard Deviation 1270
|
—
|
673 Nanogram per milliliter
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 2 and 3: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1Population: PK -evaluable set included treated participants with adequate blood sampling to estimate at least one PK parameter. Here, "Number of participants analyzed" signifies number of evaluable participants for this outcome measure. Data for only those arms \[according to dose\] are reported for this outcome measure which had any evaluable participants.
Results for this outcome measure was reported for Part 2 and Part 3 combined.
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=36 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=133 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
n=1 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2 and 3 Combined: Area Under the Plasma Concentration Time Curve From Time Zero to 168 (AUC[0-168]) of TTI-621
|
—
|
—
|
—
|
—
|
9330 Nanogram*hour per milliliter
Standard Deviation 10300
|
20000 Nanogram*hour per milliliter
Standard Deviation 10400
|
—
|
16100 Nanogram*hour per milliliter
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 2 and 3: Week 1 end of infusion (EOI)Population: Safety population included all the participants who received at least one dose of study treatment. Here, "Number of participants analyzed" signifies number of evaluable participants for this outcome measure.
CD47 is a cell-surface protein expressed on multiple normal cell types and often at high levels on many malignant tumour cells. Results are reported for combined Part 2 and 3.
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=33 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=113 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2 and 3 Combined: Percentage of CD47 Receptor Occupancy on Peripheral Blood CD3+ Cells
|
—
|
—
|
—
|
—
|
24.99 Percentage of Cells
Standard Deviation 16.54
|
31.39 Percentage of Cells
Standard Deviation 17.28
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 2 and 3: From pre-infusion on day 1 up to end of study treatment (maximum treatment exposure for Part 2 was 1793 days and for Part 3 was 938 days)Population: Immunogenicity analysis population included all treated participants with at least one ADA sample (pre-dose or post-treatment) analyzed. Here, "Number of Participants Analyzed" signifies number of participants who were ADA or NAb evaluable.
A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participants had \>1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \> 4-fold dilution increase in titer from baseline in \> 1 post-treatment sample (treatment-boosted).
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=94 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=11 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
n=36 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
n=37 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2 and 3: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb)
NAb Positive: Overall Incidence
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 and 3: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb)
ADA Positive: Overall Incidence
|
—
|
—
|
—
|
—
|
14 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)Population: Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
ORR is presented in this outcome measure as number of responders. Responders were those who had complete remission and partial remission. Lugano classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) were used for tumor response assessment for lymphomas by computed tomography (CT)-based criteria and complete metabolic response (CMR) or partial metabolic response (PMR) by positron emission tomography (PET-CT) based criteria were used for evaluation. Lymphomas evaluated by Lugano Classification include aggressive B-cell lymphoma (ABCL), Hodgkin's lymphoma (HL), Non-Hodgkin's lymphoma, indolent B-cell lymphoma (IBCL), peripheral T-cell lymphoma (PTCL), and part of T-cell lymphoma (TCL).
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=5 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=13 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
n=5 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
n=11 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
n=40 Participants
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
n=21 Participants
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
n=11 Participants
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2 and 3: Overall Response Rate (ORR) - Lugano Classification (Cheson 2014) and Refinement (Cheson 2016) Disease Indications and Nivolumab/Rituximab Combinations
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
9 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)Population: Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
ORR is presented in this outcome measure as number of responders. Responders were those who had complete response and partial response. Clinical endpoints and response criteria (Olsen et al., 2011) for in CTCL (mycosis fungoides and Sezary syndrome) and TCL were used for assessment. Tumor types evaluated included Cutaneous T-cell lymphoma (CTCL) and a part of T-cell lymphoma (TCL).
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=21 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=29 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts 2 and 3: Overall Response Rate (ORR)-Olsen 2011-Disease Indication
|
—
|
—
|
—
|
—
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)Population: Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
ORR is presented in this outcome measure as number of responders. Responders were those who had complete remission, partial remission and marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in adults (Savona et al., 2015) was used for assessment of tumors. Tumor types evaluated include Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN).
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=6 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Overall Response Rate (ORR)-Savona 2015- Disease Indication
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)Population: Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
ORR is presented in this outcome measure as number of responders. Responders were those who had complete response or complete remission, complete response or complete remission with incomplete marrow recovery, partial response. International Workshop on CLL update of the NCI 1996 Guidelines (Hallek et al., 2008) was used for assessment of tumors. Tumor types evaluated include chronic lymphocytic leukemia (CLL).
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Overall Response Rate (ORR)- Hallek 2008- Disease Indication
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)Population: Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
ORR is presented in this outcome measure as number of responders. Responders were those who had complete response, stringent complete response, very good partial response, partial response. International Uniform Response Criteria for Multiple Myeloma (Durie et al., 2006). was used for assessment of tumors.Tumor types evaluated include Multiple Myeloma (MM).
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=8 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Overall Response Rate (ORR)- Durie 2006- Disease Indication
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)Population: Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
ORR is presented in this outcome measure as number of responders. Responders were those who had morphologic leukemia-free state, morphologic complete remission, morphologic complete remission with incomplete blood count recovery, partial remission. International Working Group for trials in AML (Cheson et al., 2003) was used for assessment of tumor. Tumor types evaluated include Acute Myeloid Leukemia (AML).
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=20 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Overall Response Rate (ORR)- Cheson 2003- Disease Indication
|
—
|
—
|
—
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)Population: Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
ORR is presented in this outcome measure as number of responders. Responders were those who had irComplete Response, IrPartial Response. Immune-Related Response Criteria: RECIST (Bohnsack et al., 2014) was used for assessment of tumor. Tumor types evaluated included Small Cell Lung Cancer (SCLC).
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=4 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Overall Response Rate (ORR)- Bohnsack 2014- Disease Indication
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)Population: Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
DoR was defined, in participants who achieved a response as time from the first date of response to the first date of recurrent or progression disease. Participants without recurrent or progression disease were censored on date of the last adequate disease assessment, date of initiation of anticancer treatment or death of death, whichever was the earliest.
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
n=9 Participants
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
n=2 Participants
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
n=8 Participants
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=1 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=2 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
n=1 Participants
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
n=4 Participants
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
n=3 Participants
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts 2 and 3: Duration of Response (DoR)- Disease Indication and Nivolumab/Rituximab Combinations
|
3.1 Months
Interval 1.9 to 21.3
|
—
|
1.9 Months
Interval 1.8 to
Upper limit of 95% CI could not be estimated due to less number of participants with events.
|
8.3 Months
Interval 1.0 to
Upper limit of 95% CI could not be estimated due to less number of participants with events.
|
NA Months
Median and 95% CI could not be estimated due to less number of participants with events.
|
NA Months
Median and 95% CI could not be estimated due to less number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
8.3 Months
95% CI could not be estimated due to less number of participants with events.
|
9.2 Months
95% CI could not be estimated due to less number of participants with events.
|
12.0 Months
95% CI could not be estimated due to less number of participants with events.
|
SECONDARY outcome
Timeframe: From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)Population: Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
PFS was defined as the number of weeks from the date of the first dose of study drug to the earliest of documented recurrent or progressive disease or death due to any cause without prior progression. The progression or censoring date was determined based on described conventions (Food and Drug Administration, 2007). Kaplan-Meier method was used.
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
n=37 Participants
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
n=9 Participants
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
n=22 Participants
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=17 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
n=2 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
n=9 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
n=5 Participants
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
n=8 Participants
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
n=2 Participants
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
n=5 Participants
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
n=14 Participants
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts 2 and 3: Progression Free Survival (PFS)
|
1.7 Months
Interval 1.5 to 2.3
|
—
|
5.4 Months
Interval 1.9 to 10.8
|
2.6 Months
Interval 1.6 to 15.8
|
1.6 Months
Interval 0.7 to
Upper limit of 95% CI could not be estimated due to less number of participants with events.
|
0.8 Months
Interval 0.7 to 1.0
|
1.4 Months
Interval 0.8 to
Upper limit of 95% CI could not be estimated due to less number of participants with events.
|
3.1 Months
Interval 1.0 to 4.4
|
1.4 Months
Interval 0.7 to
Upper limit of 95% CI could not be estimated due to less number of participants with events.
|
0.8 Months
Interval 0.7 to
Upper limit of 95% CI could not be estimated due to less number of participants with events.
|
1.1 Months
Interval 0.7 to 1.3
|
11.0 Months
Interval 5.6 to
Upper limit of 95% CI could not be estimated due to less number of participants with events.
|
3.5 Months
Interval 0.7 to
Upper limit of 95% CI could not be estimated due to less number of participants with events.
|
1.7 Months
Interval 1.5 to 3.1
|
SECONDARY outcome
Timeframe: Part 4: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1Population: The Pharmacokinetic (PK)-evaluable Set consists of treated participants with adequate blood sampling to estimate at least one pharmacokinetic PK parameter. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
n=5 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
n=2 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
n=10 Participants
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
n=1 Participants
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 4: Maximum Plasma Concentration (Cmax) of TTI-621
|
—
|
—
|
—
|
—
|
4040 Nanogram per milliliter
Standard Deviation 110
|
6190 Nanogram per milliliter
Standard Deviation 1100
|
10000 Nanogram per milliliter
Standard Deviation 4400
|
15400 Nanogram per milliliter
Standard Deviation 2470
|
23600 Nanogram per milliliter
Standard Deviation 4530
|
18800 Nanogram per milliliter
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 4: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1Population: PK -evaluable set included treated participants with adequate blood sampling to estimate at least one PK parameter. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
n=5 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
n=2 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
n=8 Participants
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 4: Area Under the Plasma Concentration Time Curve From Time Zero to 168 (AUC[0-168]) of TTI-621
|
—
|
—
|
—
|
—
|
88800 Nanogram*hour per milliliter
Standard Deviation 12300
|
116000 Nanogram*hour per milliliter
Standard Deviation 38800
|
212000 Nanogram*hour per milliliter
Standard Deviation 85700
|
383000 Nanogram*hour per milliliter
Standard Deviation 49600
|
638000 Nanogram*hour per milliliter
Standard Deviation 120000
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 4: Week 1 end of infusion (EOI)Population: Safety population included all the participants who received at least one dose of study treatment. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
CD47 is a cell-surface protein expressed on multiple normal cell types and often at high levels on many malignant tumor cells.
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
n=4 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
n=5 Participants
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 4: Percentage of CD47 Receptor Occupancy on Peripheral Blood CD3+ Cells
|
—
|
—
|
—
|
—
|
62.25 Percentage of cells
Standard Deviation 12.65
|
65.49 Percentage of cells
Standard Deviation 24.80
|
37.17 Percentage of cells
Standard Deviation 32.93
|
57.09 Percentage of cells
Standard Deviation 23.72
|
65.00 Percentage of cells
Standard Deviation 5.97
|
49.51 Percentage of cells
Standard Deviation 10.83
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 4: From pre-infusion on day 1 up to end of study treatment (maximum treatment exposure for Part 4 was 667 days)Population: Immunogenicity analysis population includes all treated participants with at least one (ADA) Anti-Drug Antibody sample (pre-dose or post-treatment) analyzed. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
A participant was ADA (or NAb) positive if: (1) baseline titer is missing or negative and participants had \>1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \> \[4-fold dilution increase\] in titer from baseline in \> 1 post-treatment sample (treatment-boosted).
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
n=6 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
n=11 Participants
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
n=4 Participants
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 4: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb)
ADA Positive: Overall Incidence
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 4: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb)
NAb Positive: Overall Incidence
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study till the progressive disease/death or withdrawal (maximum observation 6 years 10 months)Population: Analysis population included all the participants who received at least one dose of study treatment.
ORR is presented in this outcome measure as number of responders. Responders were those who had complete response, partial response. Lymphomas evaluated include Non-Hodgkin's Lymphoma. Clinical endpoints and response criteria in mycosis fungoides and Sezary syndrome (Olsen et al., 2011).
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
n=6 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
n=3 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
n=12 Participants
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
n=4 Participants
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 4: Overall Response Rate (ORR)
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study till the progressive disease/death or withdrawal (maximum observation 6 years 10 months)Population: Analysis population included all the participants who received at least one dose of study treatment. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
DoR was defined, in participants who achieved a response as time from the first date of response to the first date of recurrent or progression disease. Participants without recurrent or progression disease were censored on date of the last adequate disease assessment, date of initiation of anticancer treatment or death of death, whichever was the earliest.
Outcome measures
| Measure |
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
|
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
n=1 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
n=1 Participants
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
n=2 Participants
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
|
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 4: Duration of Response (DoR)
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Months
Median and 95% CI could not be estimated due to less number of participants with events.
|
NA Months
Median and 95% CI could not be estimated due to less number of participants with events.
|
NA Months
Median and 95% CI could not be estimated due to less number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study till the progressive disease/death or withdrawal (maximum observation 6 years 10 months)Population: Data for this outcome measure is not available as analysis was not performed because: 1) due to futility and heterogenicity of respective data of the parameters of organ system (i.e., skin, blood, lymph node, and viscera; 2) the Olsen 2011 criteria already defined the "Global Response Score" to determine the Global Response (GR) consisting of the 4 components which (GR) was more important assessment affecting overall prognosis.
ORR is presented in this outcome measure as number of responders.
Outcome measures
Outcome data not reported
Adverse Events
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 1 deaths
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy
Serious events: 43 serious events
Other events: 100 other events
Deaths: 52 deaths
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Serious events: 13 serious events
Other events: 34 other events
Deaths: 27 deaths
Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy
Serious events: 15 serious events
Other events: 36 other events
Deaths: 16 deaths
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Serious events: 3 serious events
Other events: 12 other events
Deaths: 5 deaths
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg
n=3 participants at risk
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 milligram per kilogram (mg/kg) infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg
n=3 participants at risk
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg
n=7 participants at risk
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg
n=5 participants at risk
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy
n=107 participants at risk
Participants with a broader variety of hematologic malignancies and selected solid tumors, received a 0.2 mg/kg/week TTI-621 infusion until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
n=11 participants at risk
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL.If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
n=40 participants at risk
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy
n=42 participants at risk
Participants with CTCL and PTCL, received a 0.2 mg/kg/week TTI-621 infusion. Initial 2 weeks of 0.2 mg/kg treatment followed by intraparticipant dose intensification at an increment of 0.1 mg/kg per week up to 0.5 mg/kg within 5-8 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=3 participants at risk
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=3 participants at risk
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
n=6 participants at risk
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
n=3 participants at risk
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
n=12 participants at risk
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
n=4 participants at risk
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
3.7%
4/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.5%
1/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.8%
3/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.5%
1/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
3.7%
4/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.5%
1/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
5.0%
2/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia Fungal
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.5%
1/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Abdominal Infection
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.5%
1/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchitis Viral
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Campylobacter Infection
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
8.3%
1/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Covid-19 Pneumonia
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
8.3%
1/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cytomegalovirus Infection Reactivation
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
8.3%
1/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Hepatic Infection
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pelvic Infection
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.5%
1/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumococcal Infection
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia Aspiration
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.8%
3/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.8%
3/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.8%
3/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.8%
3/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Haemolytic Uraemic Syndrome
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombotic Thrombocytopenic Purpura
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.8%
3/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
8.3%
1/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Depressed Level Of Consciousness
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
1.9%
2/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
5.0%
2/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.5%
1/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.5%
1/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
1.9%
2/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
General disorders
Death
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.5%
1/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.5%
1/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
1.9%
2/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.5%
1/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
1.9%
2/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
14.3%
1/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Painful Respiration
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.5%
1/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Erythroid Leukaemia
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.5%
1/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cutaneous T-Cell Lymphoma
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Pleural Effusion
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.5%
1/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Immune system disorders
Graft Versus Host Disease
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Immune system disorders
Haemophagocytic Lymphohistiocytosis
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Investigations
Influenza A Virus Test Positive
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Exfoliative Generalised
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Intramedullary Rod Insertion
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.93%
1/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg
n=3 participants at risk
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 milligram per kilogram (mg/kg) infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg
n=3 participants at risk
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg
n=7 participants at risk
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg
n=5 participants at risk
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy
n=107 participants at risk
Participants with a broader variety of hematologic malignancies and selected solid tumors, received a 0.2 mg/kg/week TTI-621 infusion until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
n=11 participants at risk
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL.If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
n=40 participants at risk
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
|
Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy
n=42 participants at risk
Participants with CTCL and PTCL, received a 0.2 mg/kg/week TTI-621 infusion. Initial 2 weeks of 0.2 mg/kg treatment followed by intraparticipant dose intensification at an increment of 0.1 mg/kg per week up to 0.5 mg/kg within 5-8 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
n=3 participants at risk
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
n=3 participants at risk
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
n=6 participants at risk
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
n=3 participants at risk
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
n=12 participants at risk
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
n=4 participants at risk
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
66.7%
2/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
57.1%
4/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
36.4%
39/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
45.0%
18/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
31.0%
13/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
4/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
General disorders
Chills
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
28.6%
2/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
26.2%
28/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
45.5%
5/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
12.5%
5/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
38.1%
16/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
21.5%
23/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
27.3%
3/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
25.0%
10/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
23.8%
10/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
16.7%
2/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
8.4%
9/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
18.2%
2/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
12.5%
5/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
66.7%
2/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
57.1%
4/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
80.0%
4/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
41.1%
44/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
45.5%
5/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
42.5%
17/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
14/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
66.7%
2/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
66.7%
4/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
66.7%
2/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
41.7%
5/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
100.0%
4/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
14.3%
1/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
10.3%
11/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
7.5%
3/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
11.9%
5/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
8.3%
1/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
26.2%
28/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
27.3%
3/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
20.0%
8/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
14.3%
6/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
8.3%
1/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
57.1%
4/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
60.0%
3/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
21.5%
23/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
18.2%
2/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
20.0%
8/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
11.9%
5/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
8.3%
1/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
18.7%
20/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
18.2%
2/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
17.5%
7/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
14.3%
1/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
10.3%
11/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
27.3%
3/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
15.0%
6/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
6.5%
7/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
7.5%
3/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
8.3%
1/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
29.0%
31/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
36.4%
4/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
25.0%
10/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
19.0%
8/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
16.7%
2/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
50.0%
2/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
14.3%
1/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
21.5%
23/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
27.3%
3/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
15.0%
6/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
14.3%
6/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
16.7%
2/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
6.5%
7/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
7.5%
3/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
8.3%
1/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
14.3%
1/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
11.2%
12/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
22.5%
9/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
11.9%
5/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
14.3%
1/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
11.2%
12/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
12.5%
5/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
7.5%
8/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
54.5%
6/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
11.9%
5/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
28.6%
2/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
5.6%
6/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
10.0%
4/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
18.7%
20/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
27.3%
3/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
17.5%
7/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
23.8%
10/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
66.7%
8/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
14.3%
1/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
7.5%
8/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
10.0%
4/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
25.0%
3/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.8%
3/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
18.2%
2/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.5%
1/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
16.7%
2/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
42.9%
3/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
18.7%
20/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
36.4%
4/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
10.0%
4/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
11.9%
5/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
66.7%
2/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
16.7%
2/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
15.0%
16/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
7.5%
3/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
14.3%
6/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
16.7%
2/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
28.6%
2/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
15.9%
17/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
7.5%
3/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
21.4%
9/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
16.7%
2/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
14.3%
1/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
13.1%
14/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
20.0%
8/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
14.3%
6/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
8.3%
1/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
14.0%
15/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
12.5%
5/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
14.0%
15/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
18.2%
2/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.5%
1/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
66.7%
2/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
10.3%
11/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
10.0%
4/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
19.0%
8/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
66.7%
2/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
16.7%
2/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
4.7%
5/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
5.0%
2/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
13.1%
14/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
15.0%
6/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
14.3%
1/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
6.5%
7/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
8.3%
1/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
14.3%
1/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
6.5%
7/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
10.0%
4/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
50.0%
2/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
11.2%
12/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
5.0%
2/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
33.3%
1/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/7 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
9.3%
10/107 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
2.5%
1/40 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/3 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/12 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
|
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 publication 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