Trial Outcomes & Findings for A Dose Escalation Study Of PF-06939999 In Participants With Advanced Or Metastatic Solid Tumors (NCT NCT03854227)
NCT ID: NCT03854227
Last Updated: 2025-01-13
Results Overview
DLTs=any of the following adverse events (AEs) occurring in the DLT observation period (first treatment cycle):1) Any Grade 4 hematologic AEs; Grade 4 neutropenia, febrile neutropenia, Grade 3 neutropenia with infection, Grade 3 thrombocytopenia with ≥Grade 2 clinically significant bleeding, Grade 3 anemia requiring blood transfusion; 2) Any Grade ≥3 non-hematologic AEs; Grade 3 nausea/vomiting or diarrhea lasting ≥4 days after treatment, confirmed drug induced liver injury meeting Hy's law criteria; a hepatic transaminase or alkaline phosphatase level \>10 times the upper limit of normal for participants with Grade 2 hepatic transaminase or alkaline phosphatase levels at baseline as a result of liver/bone metastasis; clinically important or persistent toxicities; 3) Any toxicity causing \>2 weeks of dose delay; 4) any dose reduction due to AE during the first cycle. Grades of AEs were defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
54 participants
Primary outcome timeframe
Baseline through day 29.
Results posted on
2025-01-13
Participant Flow
Twenty-eight participants were enrolled in the dose escalation part (Part 1A) and a 26 participants were enrolled in the dose expansion part (Part 2A, Part 2B and Part 2C). A total of 54 participants were assigned to treatment and treated. The study was terminated during dose expansion part due to strategy reason but not safety concerns. No enrollments occurred in Part 1B and Part 2D prior to study termination. In Part 2B, no enrollments occurred for the food-effect substudy.
Participant milestones
| Measure |
Part 1A: PF-06939999 0.5 mg Once Daily (QD)
Part 1 is dose escalation part. Participants received PF-06939999 0.5 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 0.5 mg Twice Daily (BID)
Participants received PF-06939999 0.5 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 1 mg BID
Participants received PF-06939999 1 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
2
|
3
|
3
|
4
|
3
|
6
|
5
|
14
|
2
|
10
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
3
|
3
|
4
|
3
|
6
|
5
|
14
|
2
|
10
|
Reasons for withdrawal
| Measure |
Part 1A: PF-06939999 0.5 mg Once Daily (QD)
Part 1 is dose escalation part. Participants received PF-06939999 0.5 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 0.5 mg Twice Daily (BID)
Participants received PF-06939999 0.5 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 1 mg BID
Participants received PF-06939999 1 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
3
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
1
|
|
Overall Study
Progressive disease
|
1
|
1
|
1
|
2
|
3
|
1
|
2
|
5
|
2
|
5
|
1
|
6
|
|
Overall Study
Study terminated by sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Disease relapse
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Global deterioration of health status
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Refused further treatment
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
Baseline Characteristics
A Dose Escalation Study Of PF-06939999 In Participants With Advanced Or Metastatic Solid Tumors
Baseline characteristics by cohort
| Measure |
Part 1A: PF-06939999 0.5 mg QD
n=1 Participants
Part 1 is dose escalation part. Participants received PF-06939999 0.5 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 0.5 mg BID
n=1 Participants
Participants received PF-06939999 0.5 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 1 mg BID
n=2 Participants
Participants received PF-06939999 1 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
n=3 Participants
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
n=3 Participants
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
n=4 Participants
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
n=3 Participants
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
n=6 Participants
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
n=5 Participants
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=14 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=2 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=10 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
45-64 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
25 Participants
n=36 Participants
|
|
Age, Customized
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
26 Participants
n=36 Participants
|
|
Age, Continuous
|
81.00 Years
n=5 Participants
|
54.00 Years
n=7 Participants
|
65.00 Years
n=5 Participants
|
57.00 Years
n=4 Participants
|
72.00 Years
n=21 Participants
|
59.50 Years
n=8 Participants
|
69.00 Years
n=8 Participants
|
59.00 Years
n=24 Participants
|
69.00 Years
n=42 Participants
|
66.50 Years
n=42 Participants
|
65.00 Years
n=42 Participants
|
67.50 Years
n=42 Participants
|
64.00 Years
n=36 Participants
|
|
Age, Customized
<18 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
|
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
|
|
Age, Customized
18-44 years
|
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
|
1 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
|
3 Participants
n=36 Participants
|
|
Age, Customized
Unspecified
|
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
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
23 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
31 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
39 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
44 Participants
n=36 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline through day 29.Population: The analysis population included participants in Part 1A who had at least one dose of study treatment and either experienced DLT or did not have major treatment deviations during the DLT observation period.
DLTs=any of the following adverse events (AEs) occurring in the DLT observation period (first treatment cycle):1) Any Grade 4 hematologic AEs; Grade 4 neutropenia, febrile neutropenia, Grade 3 neutropenia with infection, Grade 3 thrombocytopenia with ≥Grade 2 clinically significant bleeding, Grade 3 anemia requiring blood transfusion; 2) Any Grade ≥3 non-hematologic AEs; Grade 3 nausea/vomiting or diarrhea lasting ≥4 days after treatment, confirmed drug induced liver injury meeting Hy's law criteria; a hepatic transaminase or alkaline phosphatase level \>10 times the upper limit of normal for participants with Grade 2 hepatic transaminase or alkaline phosphatase levels at baseline as a result of liver/bone metastasis; clinically important or persistent toxicities; 3) Any toxicity causing \>2 weeks of dose delay; 4) any dose reduction due to AE during the first cycle. Grades of AEs were defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=1 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=1 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=2 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
n=2 Participants
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
n=3 Participants
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
n=2 Participants
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
n=3 Participants
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
n=6 Participants
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
n=4 Participants
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1A: Number of Participants With Dose-Limiting Toxicities (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to a minimum of 28 days after last dose of study treatment (maximum of 13 months)Population: The analysis set included all participants in Part 1A who received at least 1 dose of study treatment.
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Grades of AEs were defined by NCI CTCAE version 5.0. Grade 3 events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 events = events that caused participant to be in imminent danger of death. Grade 5 events = death related to an AE.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=1 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=1 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=2 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
n=3 Participants
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
n=3 Participants
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
n=4 Participants
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
n=3 Participants
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
n=6 Participants
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
n=5 Participants
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1A: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
All-Causality TEAEs
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
|
Part 1A: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
All-Causality SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Part 1A: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Maximum Grade 3 or 4 All-Causality AEs
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Part 1A: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Maximum Grade 5 All-Causality AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Part 1A: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
All-causality TEAEs Leading to Discontinuation From Study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Part 1A: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Treatment-related TEAEs
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
|
Part 1A: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Treatment-related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Maximum Grade 3 or 4 Treatment-related AEs
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Part 1A: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Maximum Grade 5 Treatment-related AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Treatment-related TEAEs leading to discontinuation form study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to a minimum of 28 days after last dose of study treatment (maximum of 12 months)Population: The analysis set included all participants in Part 1A who received at least 1 dose of study treatment. Number of Participants Analyzed = number of participants evaluable for this outcome measure. Number Analyzed = number of participants evaluable for the specific laboratory test.
Laboratory assessments included hematology, chemistry and urinary tests. Participants with maximum Grade 3-4 laboratory abnormalities are reported in this OM. Grades of laboratory results were defined by NCI CTCAE version 5.0. Grade 3 events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 events = events that caused participant to be in imminent danger of death. Some of the Grade 4 events (activated partial thromboplastin time prolonged, anemia, hemoglobin increased, leukocytosis, lymphocyte count increased and hypoalbuminemia) could not be defined/determined based only on lab data, therefore are not reported in this OM.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=1 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=1 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=2 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
n=3 Participants
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
n=3 Participants
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
n=4 Participants
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
n=3 Participants
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
n=6 Participants
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
n=5 Participants
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Hypernatremia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Neutrophil Count Decreased (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Lymphocyte Count Decreased (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Lymphocyte Count Increased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Neutrophil Count Decreased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Platelet Count Decreased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Platelet Count Decreased (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
White Blood Cell Decreased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
White Blood Cell Decreased (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Alanine Aminotransferase Increased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Alanine Aminotransferase Increased (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Alkaline Phosphatase Increased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Alkaline Phosphatase Increased (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Aspartate Aminotransferase Increased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Aspartate Aminotransferase Increased (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Blood Bilirubin Increased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Blood Bilirubin Increased (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Creatinine Increased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Creatinine Increased (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Hypercalcemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Hypercalcemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Hyperkalemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Hyperkalemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Hypermagnesemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Hypermagnesemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Hypernatremia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Hypoalbuminemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Hypocalcemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Hypocalcemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Hypoglycemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Hypoglycemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Hypokalemia (Grade 3)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Hypokalemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Hypomagnesemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Hypomagnesemia (Grade 4)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Hyponatremia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Hyponatremia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Lipase Increased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Lipase Increased (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Serum Amylase Increased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Serum Amylase Increased (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Activated Partial Thromboplastin Time Prolonged (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Anemia (Grade 3)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Hemoglobin Increased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Leukocytosis (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1A: Number of Participants With Laboratory Abnormalities
Lymphocyte Count Decreased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline up to a minimum of 28 days after last dose of study treatment (maximum of 15 months)Population: The analysis set included all participants in Part 2 who received at least 1 dose of study treatment.
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Grades of AEs were defined by NCI CTCAE version 5.0. Grade 3 events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 events = events that caused participant to be in imminent danger of death. Grade 5 events = death related to an AE.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=14 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=2 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=10 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With TEAEs
All-Causality TEAEs
|
14 Participants
|
2 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With TEAEs
All-Causality SAEs
|
7 Participants
|
1 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With TEAEs
Maximum Grade 3 or 4 All-Causality AEs
|
11 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With TEAEs
Maximum Grade 5 All-Causality AEs
|
3 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With TEAEs
All-causality TEAEs Leading to Discontinuation From Study
|
3 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With TEAEs
Treatment-related TEAEs
|
10 Participants
|
2 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With TEAEs
Treatment related SAEs
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With TEAEs
Maximum Grade 3 or 4 Treatment-related AEs
|
5 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With TEAEs
Maximum Grade 5 Treatment-related AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With TEAEs
Treatment-related TEAEs leading to discontinuation form study
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to a minimum of 28 days after last dose of study treatment (maximum of 8 months)Population: The analysis set included all participants in Part 2 who received at least 1 dose of study treatment. Number of Participants Analyzed = number of participants evaluable for this outcome measure. Number Analyzed = number of participants evaluable for the specific laboratory test.
Laboratory assessments included hematology, chemistry and urinary tests. Participants with maximum Grade 3-4 laboratory abnormalities are reported in this OM. Grades of laboratory results were defined by NCI CTCAE version 5.0. Grade 3 events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 events = events that caused participant to be in imminent danger of death. Some of the Grade 4 events (activated partial thromboplastin time prolonged, anemia, hemoglobin increased, leukocytosis, lymphocyte count increased and hypoalbuminemia) could not be defined/determined based only on lab data, therefore are not reported in this OM.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=14 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=2 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=10 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Laboratory Abnormalities
Hypomagnesemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Activated Partial Thromboplastin Time Prolonged (Grade 3)
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Anemia (Grade 3)
|
5 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Hemoglobin Increased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Leukocytosis (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Lymphocyte Count Decreased (Grade 3)
|
4 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Lymphocyte Count Decreased (Grade 4)
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Lymphocyte Count Increased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Neutrophil Count Decreased (Grade 3)
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Neutrophil Count Decreased (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Platelet Count Decreased (Grade 3)
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Platelet Count Decreased (Grade 4)
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
White Blood Cell Decreased (Grade 3)
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
White Blood Cell Decreased (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Alanine Aminotransferase Increased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Alanine Aminotransferase Increased (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Alkaline Phosphatase Increased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Alkaline Phosphatase Increased (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Aspartate Aminotransferase Increased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Aspartate Aminotransferase Increased (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Blood Bilirubin Increased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Blood Bilirubin Increased (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Creatinine Increased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Creatinine Increased (Grade 4)
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Hypercalcemia (Grade 3)
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Hypercalcemia (Grade 4)
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Hyperkalemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Hyperkalemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Hypermagnesemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Hypermagnesemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Hypernatremia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Hypernatremia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Hypoalbuminemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Hypocalcemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Hypocalcemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Hypoglycemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Hypoglycemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Hypokalemia (Grade 3)
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Hypokalemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Hypomagnesemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Hyponatremia (Grade 3)
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Hyponatremia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Lipase Increased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Lipase Increased (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Serum Amylase Increased (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Laboratory Abnormalities
Serum Amylase Increased (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From baseline up to 28 ~ 35 days after end of treatment (maximum of 6 months).Population: The analysis population included all participants in Part 2 who received at least one dose of study treatment and had baseline disease assessment or measurable disease at baseline, if applicable and at least one post baseline disease assessment.
Number of participants with BOR assessed using Response Evaluation Criteria in Solid Tumor (RECIST) v1.1: Complete Response (CR): disappearance of all lesions (with the exception of nodal disease when assessing target lesions). Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered a sign of progression. Stable disease (SD): does not qualify for CR, PR or PD. Non-CR/Non-PD: Persistence of any non target lesions and/or tumor marker level above the normal limits.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=11 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=2 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=8 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Best Overall Response (BOR) Based on Investigator Assessment (RECIST, Version 1.1)
Complete response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Best Overall Response (BOR) Based on Investigator Assessment (RECIST, Version 1.1)
Partial response (PR)
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Best Overall Response (BOR) Based on Investigator Assessment (RECIST, Version 1.1)
Stable disease (SD)
|
4 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Best Overall Response (BOR) Based on Investigator Assessment (RECIST, Version 1.1)
Non-CR/Non-PD
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Best Overall Response (BOR) Based on Investigator Assessment (RECIST, Version 1.1)
Progressive disease (PD)
|
4 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Best Overall Response (BOR) Based on Investigator Assessment (RECIST, Version 1.1)
Not evaluable (NE)
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5 hour, 1 hour, 2 hours, 4 hours, 6 hours and 12 hours post the morning dose on Cycle 1 Day 1.Population: The analysis population included enrolled participants in Part 1A treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest.
Maximum plasma concentration of PF-06939999 after the participant received a SD on Cycle 1 Day 1. Cmax was directly observed from data.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=1 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=1 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=2 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
n=3 Participants
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
n=3 Participants
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
n=4 Participants
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
n=3 Participants
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
n=6 Participants
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
n=5 Participants
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1A: PK Parameters of PF-06939999: Single Dose (SD) - Maximum Observed Plasma Concentration (Cmax)
|
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric mean and geometric coefficient of variation (CV) are not applicable due to n\<3.
|
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
6.295 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 13
|
26.33 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 70
|
26.64 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 63
|
52.96 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 85
|
28.56 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 72
|
21.63 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 82
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6 and 12 hours post the morning dose on Cycle 1 Day 1.Population: The analysis population included enrolled participants in Part 1A treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest.
Time to maximum plasma concentration of PF-06939999 after the participant received a SD on Cycle 1 Day 1. Tmax was observed directly from data.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=1 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=1 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=2 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
n=3 Participants
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
n=3 Participants
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
n=4 Participants
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
n=3 Participants
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
n=6 Participants
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
n=5 Participants
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1A: PK Parameters of PF-06939999: SD - Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
0.9 hours (hr)
Interval 0.9 to 0.9
|
2.0 hours (hr)
Interval 2.0 to 2.0
|
2.1 hours (hr)
Interval 2.1 to 2.1
|
1.0 hours (hr)
Interval 0.5 to 2.1
|
1.0 hours (hr)
Interval 0.5 to 3.7
|
1.5 hours (hr)
Interval 0.5 to 4.0
|
2.0 hours (hr)
Interval 1.0 to 2.1
|
1.5 hours (hr)
Interval 0.7 to 2.2
|
0.9 hours (hr)
Interval 0.5 to 4.3
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6 and 12 hours post the morning dose on Cycle 1 Day 1.Population: The analysis population included enrolled participants in Part 1A treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest with evaluable data that contributed to the summary statistics of this outcome measure (OM).
Area under the plasma concentration versus time curve (AUC) from time 0 to the last measured concentration (AUClast) after the participant received a SD of PF-06939999 on Cycle 1 Day 1.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=2 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
n=3 Participants
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
n=3 Participants
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
n=4 Participants
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
n=2 Participants
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
n=4 Participants
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
n=4 Participants
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1A: PK Parameters of PF-06939999: SD - Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
|
—
|
—
|
NA nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
20.52 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 15
|
93.77 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 61
|
88.94 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 51
|
NA nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
256.7 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 75
|
136.4 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 94
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6 and 12 hours post the morning dose on Cycle 1 Day 15.Population: The analysis population included enrolled participants in Part 1A treated who did not had protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest, with evaluable data that contributed to the summary statistics of this OM.
Cmax,ss was the steady-state maximum concentration of PF-06939999 after MD. Cmax,ss was observed directly from the data.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=1 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=1 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=2 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
n=2 Participants
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
n=3 Participants
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
n=1 Participants
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
n=2 Participants
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
n=6 Participants
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
n=3 Participants
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1A: PK Parameters of PF-06939999: Multiple Dose (MD) - Steady State Maximum Observed Plasma Concentration (Cmax,ss)
|
NA ng/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
NA ng/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
NA ng/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
NA ng/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
59.78 ng/mL
Geometric Coefficient of Variation 37
|
NA ng/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
NA ng/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
59.32 ng/mL
Geometric Coefficient of Variation 26
|
29.39 ng/mL
Geometric Coefficient of Variation 99
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6 and 12 hours post the morning dose on Cycle 1 Day 15.Population: The analysis population included enrolled participants in Part 1A treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest, with evaluable data that contributed to the summary statistics of this OM.
Tmax,ss was the steady-state time to maximum plasma concentration of PF-06939999 after MD. Tmax,ss was observed directly from data.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=1 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=1 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=2 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
n=2 Participants
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
n=3 Participants
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
n=1 Participants
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
n=2 Participants
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
n=6 Participants
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
n=3 Participants
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1A: PK Parameters of PF-06939999: MD - Steady State Time to Reach Maximum Observed Plasma Concentration (Tmax,ss)
|
0.5 hr
Interval 0.5 to 0.5
|
5.6 hr
Interval 5.6 to 5.6
|
0.75 hr
Interval 0.5 to 1.0
|
1.6 hr
Interval 1.0 to 2.2
|
0.5 hr
Interval 0.5 to 1.9
|
1.0 hr
Interval 1.0 to 1.0
|
1.5 hr
Interval 1.0 to 2.0
|
1.0 hr
Interval 0.5 to 2.2
|
1.9 hr
Interval 0.5 to 2.1
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6 and 12 hours post the morning dose on Cycle 1 Day 15.Population: The analysis population included enrolled participants in Part 1A treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest, with evaluable data that contributed to the summary statistics of this OM.
AUCtau,ss was the steady-state area under the concentration-time profile from time zero to time tau (τ) of PF-06939999 after MD.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=1 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=1 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=2 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
n=2 Participants
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
n=3 Participants
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
n=1 Participants
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
n=2 Participants
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
n=6 Participants
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
n=3 Participants
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1A: PK Parameters of PF-06939999: MD - Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau,ss)
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
437.4 ng*hr/mL
Geometric Coefficient of Variation 31
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
718.3 ng*hr/mL
Geometric Coefficient of Variation 38
|
360.6 ng*hr/mL
Geometric Coefficient of Variation 98
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6 and 12 hours post the morning dose on Cycle 1 Day 15.Population: The analysis population included enrolled participants in Part 1A treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest, with evaluable data that contributed to the summary statistics of this OM.
Apparent oral plasma clearance of PF-06939999 after MD. CL/F after multiple doses = Dose/AUCtau,ss. AUCtau,ss = area under the concentration-time profile from time zero to time tau after multiple doses.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=1 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=1 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=2 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
n=2 Participants
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
n=3 Participants
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
n=1 Participants
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
n=2 Participants
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
n=6 Participants
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
n=3 Participants
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1A: PK Parameters of PF-06939999: MD - Apparent Oral Clearance (CL/F)
|
NA liters per hour (L/hr)
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
NA liters per hour (L/hr)
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
NA liters per hour (L/hr)
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
NA liters per hour (L/hr)
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
9.163 liters per hour (L/hr)
Geometric Coefficient of Variation 31
|
NA liters per hour (L/hr)
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
NA liters per hour (L/hr)
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
8.358 liters per hour (L/hr)
Geometric Coefficient of Variation 38
|
11.09 liters per hour (L/hr)
Geometric Coefficient of Variation 98
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5 hour, 1 hour, 2 hours, 4 hours, 6 hours and 12 hours post the morning dose on Cycle 1 Day 1; Pre-dose and 0.5, 1, 2, 4, 6 and 12 hours post the morning dose on Cycle 1 Day 15.Population: The analysis population included enrolled participants in Part 1A treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest, and contributed to the summary statistics of this OM.
Rac was observed accumulation ratio based on AUCtau. Rac was calculated as AUCtau (multiple dose, Cycle 1 Day 15)/ AUCtau (single dose, Cycle 1 Day 1). AUCtau was area under the concentration-time profile from time zero to time tau (τ), the dosing interval.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=2 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
n=2 Participants
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
n=2 Participants
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
n=1 Participants
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
n=1 Participants
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
n=4 Participants
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
n=3 Participants
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1A: PK Parameters of PF-06939999: MD - Accumulation Ratio (Rac)
|
—
|
—
|
NA ratio
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
NA ratio
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
NA ratio
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
NA ratio
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
NA ratio
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
3.262 ratio
Geometric Coefficient of Variation 52
|
2.526 ratio
Geometric Coefficient of Variation 20
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5 hour, 1 hour, 2 hours and 4 hours post Cycle 1 Day 1 dosing.Population: The analysis population included enrolled participants in Part 2 treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest, with evaluable data that contributed to the summary statistics of this OM.
Maximum plasma concentration of PF-06939999 after the participant received a SD on Cycle 1 Day 1. Cmax was directly observed from data.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=13 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=2 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=10 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: PK Parameters of PF-06939999: SD - Cmax
|
38.60 ng/mL
Geometric Coefficient of Variation 93
|
NA ng/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
30.89 ng/mL
Geometric Coefficient of Variation 50
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5 hour, 1 hour, 2 hours and 4 hours post Cycle 1 Day 1 dosing.Population: The analysis population included enrolled participants in Part 2 treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest, with evaluable data that contributed to the summary statistics of this OM.
Time to maximum plasma concentration of PF-06939999 after the participant received a SD on Cycle 1 Day 1. Tmax was observed directly from data.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=13 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=2 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=10 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: PK Parameters of PF-06939999: SD - Tmax
|
0.9 hr
Interval 0.5 to 2.2
|
1.25 hr
Interval 0.5 to 2.0
|
1.0 hr
Interval 0.9 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5 hour, 1 hour, 2 hours and 4 hours post Cycle 1 Day 15 dosing.Population: The analysis population included enrolled participants in Part 2 treated who did not have protocol deviations influencing PK assessment, and have sufficient information to estimate at least 1 of the PK parameters of interest, with evaluable data that contributed to the summary statistics of this OM.
Cmax,ss was the steady-state maximum concentration of PF-06939999 after MD. Cmax,ss was observed directly from the data.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=9 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=2 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=7 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: PK Parameters of PF-06939999: MD - Cmax,ss
|
81.27 ng/mL
Geometric Coefficient of Variation 57
|
NA ng/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
50.22 ng/mL
Geometric Coefficient of Variation 40
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5 hour, 1 hour, 2 hours and 4 hours post Cycle 1 Day 15 dosing.Population: The analysis population included enrolled participants in Part 2 treated who did not have protocol deviations influencing PK assessment, and have sufficient information to estimate at least 1 of the PK parameters of interest, with evaluable data that contributed to the summary statistics of this OM.
Tmax,ss was the steady-state time to maximum plasma concentration of PF-06939999 after MD. Tmax,ss was observed directly from data.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=9 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=2 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=7 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: PK Parameters of PF-06939999: MD - Tmax,ss
|
1.1 hr
Interval 0.5 to 4.0
|
2.05 hr
Interval 2.0 to 2.1
|
2.1 hr
Interval 1.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5 hour, 1 hour, 2 hours and 4 hours post Cycle 1 Day 15 dosing.Population: The analysis population included enrolled participants in Part 2 treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest, with evaluable data that contributed to the summary statistics of this OM.
Ctrough was trough serum concentration of PF-06939999 after MD. Ctrough = Cmin.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=9 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=2 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=7 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: PK Parameters of PF-06939999: MD - Trough Concentration (Ctrough).
|
21.55 ng/mL
Geometric Coefficient of Variation 93
|
NA ng/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric CV are not applicable due to n\<3.
|
17.33 ng/mL
Geometric Coefficient of Variation 61
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 0.5, 1, 2, 4, 6 and 12 hours post dose on Cycle 1 Day 15 (fasted condition); predose and 0.5, 1, 2, 4, 6 and 12 hours post dose on Cycle 1 Day 16 (with food).Population: The analysis population included participants enrolled and treated in the food-effect substudy of Part 2B who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest. Food-effect cohort in Part 2B was not enrolled.
Maximum concentration of PF-06939999 given with and without food. On Cycle 1 Day 15, participants enrolled in the food-effect substudy of Part 2B received an oral dose of PF-06939999 under the fasted condition (overnight fasting of at least 10 hours; water permitted). On Cycle 1 Day 16, these participants received another oral dose of PF-06939999 with a high-fat, high-calorie meal (breakfast) following 10-hour overnight fasting (water permitted).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose and 0.5, 1, 2, 4, 6 and 12 hours post dose on Cycle 1 Day 15 (fasted condition); predose and 0.5, 1, 2, 4, 6 and 12 hours post dose on Cycle 1 Day 16 (with food).Population: The analysis population included participants enrolled and treated in the food-effect substudy of Part 2B who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest. Food-effect cohort in Part 2B was not enrolled.
Time to maximum plasma concentration of PF-06939999 given with and without food. On Cycle 1 Day 15, participants enrolled in the food-effect substudy of Part 2B received an oral dose of PF-06939999 under the fasted condition (overnight fasting of at least 10 hours; water permitted). On Cycle 1 Day 16, these participants received another oral dose of PF-06939999 with a high-fat, high-calorie meal (breakfast) following 10-hour overnight fasting (water permitted).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose and 0.5, 1, 2, 4, 6 and 12 hours post dose on Cycle 1 Day 15 (fasted condition); predose and 0.5, 1, 2, 4, 6 and 12 hours post dose on Cycle 1 Day 16 (with food).Population: The analysis population included participants enrolled and treated in the food-effect substudy of Part 2B who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest. Food-effect cohort in Part 2B was not enrolled.
AUClast of PF-06939999 given with and without food. On Cycle 1 Day 15, participants enrolled in the food-effect substudy of Part 2B received an oral dose of PF-06939999 under the fasted condition (overnight fasting of at least 10 hours; water permitted). On Cycle 1 Day 16, these participants received another oral dose of PF-06939999 with a high-fat, high-calorie meal (breakfast) following 10-hour overnight fasting (water permitted).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline up to 28 ~ 35 days after end of treatment (maximum of 12 months).Population: The analysis population included all participants in Part 1A who received at least one dose of study treatment and had baseline disease assessment or measurable disease at baseline, if applicable and at least one post baseline disease assessment.
Objective Response Rate (ORR) was defined as the percentage of participants who achieved CR or PR per RECIST 1.1. CR was defined as disappearance of all lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=1 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=1 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=2 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
n=2 Participants
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
n=3 Participants
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
n=2 Participants
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
n=2 Participants
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
n=6 Participants
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
n=4 Participants
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1A: Percentage of Participants With Objective Response Based on Investigator Assessment (RECIST v1.1)
|
0 Percentage of participants
Interval 0.0 to 79.3
|
0 Percentage of participants
Interval 0.0 to 79.3
|
0 Percentage of participants
Interval 0.0 to 65.8
|
50.0 Percentage of participants
Interval 9.5 to 90.5
|
33.3 Percentage of participants
Interval 6.1 to 79.2
|
0 Percentage of participants
Interval 0.0 to 65.8
|
0 Percentage of participants
Interval 0.0 to 65.8
|
0 Percentage of participants
Interval 0.0 to 39.0
|
0 Percentage of participants
Interval 0.0 to 49.0
|
SECONDARY outcome
Timeframe: From baseline up to 28 ~ 35 days after end of treatment (maximum of 12 months).Population: The analysis population included all participants in Part 1A who received at least one dose of study treatment and had baseline disease assessment or measurable disease at baseline, if applicable and at least one post baseline disease assessment, with confirmed CR or PR.
Duration of response was defined as the time from start date (which is the date of first documentation of PR or CR) to date of first documentation of objective progression or death. DOR was only applicable to those participants with an objective response (confirmed CR or PR). CR: disappearance of all lesions (with the exception of nodal disease when assessing target lesions). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
n=1 Participants
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
n=1 Participants
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1A: Duration of Response Based on Investigator Assessment (RECIST, v1.1)
|
—
|
—
|
—
|
4.3 Months
95% Confidence Interval (CI) is not applicable due to n = 1.
|
4.7 Months
95% CI is not applicable due to n = 1.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline up to 28 ~ 35 days after end of treatment (maximum of 6 months).Population: The analysis population included all participants in Part 2 who received at least one dose of study treatment and had baseline disease assessment or measurable disease at baseline, if applicable and at least one post baseline disease assessment, with confirmed CR or PR.
Duration of response was defined as the time from start date (which is the date of first documentation of PR or CR) to date of first documentation of objective progression or death. DoR was only applicable to those participants with an objective response (confirmed CR or PR). CR: disappearance of all lesions (with the exception of nodal disease when assessing target lesions). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=1 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Duration of Response Based on Investigator Assessment (RECIST, v1.1)
|
NA Months
Median and 95% CI are not applicable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline up to 28 ~ 35 days after end of treatment (maximum of 6 months).Population: The analysis population included all participants in Part 2 who received at least one dose of study treatment and had baseline disease assessment or measurable disease at baseline, if applicable and at least one post baseline disease assessment.
Progression Free Survival (PFS) was defined as the time from initiation of PF-06939999 therapy to first documentation of tumor progression or to death due to any cause, whichever occurred first.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=11 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=2 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=8 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Progression Free Survival Based on Investigator Assessment (RECIST, v1.1)
|
3.4 Months
Interval 1.1 to
The upper limit of 95% CI is not applicable due to insufficient number of participants with events.
|
5.5 Months
95% CI is not applicable due to insufficient number of participants with events.
|
1.9 Months
Interval 1.6 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline up to 28 ~ 35 days after end of treatment (maximum of 6 months).Population: The analysis population included all participants in Part 2 who received at least one dose of study treatment and had baseline disease assessment or measurable disease at baseline, if applicable and at least one post baseline disease assessment.
Time to Progression (TTP) was defined as the time from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to tumor progression. Disease progression is defined using RECIST v 1.1.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=11 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=2 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=8 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Time to Progression Based on Investigator Assessment (RECIST, v1.1)
|
3.4 Months
Interval 1.1 to
The upper limit of 95% CI is not applicable due to insufficient number of participants with events.
|
5.5 Months
95% CI is not applicable due to insufficient number of participants with events.
|
1.9 Months
Interval 1.6 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline up to maximum follow up (15 months).Population: The analysis set included all participants in Part 2 who received at least 1 dose of study treatment.
Overall Survival (OS) was defined as the time from the start date (first dose) of study treatment to the date of death due to any cause.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=14 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=2 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=10 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Overall Survival
|
6.0 Months
Interval 1.0 to
The upper limit of 95% CI is not applicable due to insufficient number of participants with events.
|
NA Months
Median and 95% CI are not applicable due to insufficient number of participants with events.
|
14.6 Months
Interval 0.8 to
The upper limit of 95% CI is not applicable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline up to maximum follow up (15 months).Population: The analysis set included all participants in Part 2 who received at least 1 dose of study treatment.
The probability of survival at select times was estimated using the Kaplan Meier method. Although an endpoint of Overall Survival at 2 years of study treatment was defined in the protocol, no data were collected/analyzed for this endpoint due to maximum follow up not reaching 2 year post study treatment.
Outcome measures
| Measure |
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=14 Participants
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=2 Participants
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=10 Participants
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Probability of Survival at 6 Months and 1 Year of PF-06939999 Monotherapy
6 Months
|
0.550 probability of survival
Interval 0.258 to 0.768
|
1.000 probability of survival
Interval 1.0 to 1.0
|
0.778 probability of survival
Interval 0.365 to 0.939
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Probability of Survival at 6 Months and 1 Year of PF-06939999 Monotherapy
1 Year
|
0.283 probability of survival
Interval 0.073 to 0.543
|
NA probability of survival
Probability of survival and 95% CI are not applicable due to insufficient number of participants with events.
|
0.519 probability of survival
Interval 0.084 to 0.84
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1A: PF-06939999 0.5 mg QD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1A: PF-06939999 0.5 mg BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1A: PF-06939999 1 mg BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1A: PF-06939999 2 mg BID
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1A: PF-06939999 4 mg BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1A: PF-06939999 6 mg BID
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Part 1A: PF-06939999 8 mg QD
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Part 1A: PF-06939999 6 mg QD
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1A: PF-06939999 4 mg QD
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
Serious events: 7 serious events
Other events: 12 other events
Deaths: 9 deaths
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
Serious events: 5 serious events
Other events: 10 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Part 1A: PF-06939999 0.5 mg QD
n=1 participants at risk
Part 1 is dose escalation part. Participants received PF-06939999 0.5 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 0.5 mg BID
n=1 participants at risk
Participants received PF-06939999 0.5 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 1 mg BID
n=2 participants at risk
Participants received PF-06939999 1 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
n=3 participants at risk
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
n=3 participants at risk
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
n=4 participants at risk
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
n=3 participants at risk
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
n=6 participants at risk
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
n=5 participants at risk
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=14 participants at risk
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=2 participants at risk
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=10 participants at risk
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Disease progression
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
2/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
2/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Arterial rupture
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Embolism
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
2/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Part 1A: PF-06939999 0.5 mg QD
n=1 participants at risk
Part 1 is dose escalation part. Participants received PF-06939999 0.5 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 0.5 mg BID
n=1 participants at risk
Participants received PF-06939999 0.5 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 1 mg BID
n=2 participants at risk
Participants received PF-06939999 1 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 2 mg BID
n=3 participants at risk
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg BID
n=3 participants at risk
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg BID
n=4 participants at risk
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 8 mg QD
n=3 participants at risk
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 6 mg QD
n=6 participants at risk
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 1A: PF-06939999 4 mg QD
n=5 participants at risk
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
n=14 participants at risk
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
n=2 participants at risk
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin \[MVAC\]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
n=10 participants at risk
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
60.0%
3/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
28.6%
4/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
5/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
4/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
1/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Cataract
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Scleral oedema
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
21.4%
3/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
1/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
2/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
2/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
100.0%
1/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
3/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
83.3%
5/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
2/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
7/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
4/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Pancreatic failure
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
1/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
21.4%
3/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chest discomfort
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chest pain
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chills
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
1/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
4/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
60.0%
3/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
28.6%
4/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
5/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Influenza like illness
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Malaise
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
2/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pain
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Cystitis
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Ear infection
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Infection
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Skin candida
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
2/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Amylase increased
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood creatinine increased
|
100.0%
1/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Lipase increased
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
35.7%
5/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
2/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
30.0%
3/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Weight increased
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
2/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
83.3%
5/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
35.7%
5/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
4/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
1/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
100.0%
1/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
2/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
4/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
35.7%
5/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
1/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
1/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
2/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
3/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
2/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
60.0%
3/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
35.7%
5/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Migraine
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Tremor
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Product Issues
Device malfunction
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Nephropathy
|
100.0%
1/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
28.6%
4/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
100.0%
1/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
1/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
2/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
100.0%
1/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
2/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Orthostatic hypertension
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER